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  6. Examples of Medical Device Misconnections
  1. Medical Device Connectors

Examples of Medical Device Misconnections

The FDA has recognized voluntary consensus standards for certain medical device connector designs intended to enhance device safety such as the ISO 80369 series. Many such connectors that rely on the ISO 80369 standards are currently available and are also incorporated into product specific standards.

Connectors that conform to these standards are designed to help reduce the risk of medical device misconnections. As new connector designs for high-risk delivery systems become more widely available, the likelihood for medical device misconnections is expected to decrease. In addition to these standards, standards development organizations are developing standards applicable to connectors for other medical applications. 

If the connectors you use do not conform to one of these standards, or the connectors do not yet have an applicable standard, misconnections can still occur. The case studies on this page describe device misconnections that have been reported to the FDA.  This page offers patients and health care providers safety tips and recommendations to reduce device misconnections. The potential for harm designations: High, Medium and Low refer to the severity of patient harm that could result from the depicted type of misconnection. 

For more information on Medical Device Connectors, including tips for health care providers, reducing risks through the use of standards, and how to report a problem, visit our resources below:

Medical Device Connectors 
Information for Health Care Facilities about Medical Device Connectors 
Tips for Health Care Providers to Reduce Medical Device Misconnections 
Reducing Risks through Standards Development for Medical Device Connectors 
Report a Problem to the FDA About Medical Device Misconnections 

On this page:

Epidural tubing erroneously connected to IV tubing

Epidural tubing erroneously connected to IV tubing on mannequin arm

Case Study

  • An anesthetist and a midwife mistakenly connected an epidural set to the patient’s IV tubing
  • The epidural medicine was delivered to the IV
  • The patient died

Potential for Harm: High

Tips to Reduce Device Misconnections: For certain high-risk catheters (e.g., epidural, intrathecal, arterial), label the catheter and do not use catheters that have injection ports

IV tubing erroneously connected to trach cuff

IV tubing erroneously connected to trach cuff on mannequin laying in hospital bed.

Case Study 

  • A child in a pediatric intensive care unit had both an IV line and a trach tube
  • The IV tubing was mistakenly connected to the trach cuff port
  • The IV fluid over-expanded the trach cuff to the point of breaking and continuous IV fluids entered the child’s lungs
  • The child died

Potential for Harm: High

Tips to Reduce Device Misconnections: Emphasize the risk of tubing misconnections in orientation and training

IV tubing erroneously connected to nebulizer

Tubing erroneously connected to nebulizer on mannequin in in hospital bed

Case Study 

  • During a nebulizer treatment, the patient’s oxygen tubing fell off the nebulizer and the patient’s IV tubing was inadvertently attached to the nebulizer
  • When the patient inhaled, a moderate amount of IV fluids was aspirated into the patient’s lungs
  • The misconnection was identified by the respiratory therapist and the patient survived

Potential for Harm: High

Tips to Reduce Device Misconnections: Do not purchase non-intravenous equipment that is equipped with connectors that can physically mate or attach with a female Luer IV line connector

Oxygen tubing erroneously connected to a needleless IV port

Oxygen tubing erroneously connected to a needleless IV port on mannequin arm

Case Study 

  • A patient’s oxygen tubing became disconnected from his nebulizer and was accidentally reattached to his IV tubing Y-site by a staff member who was completing a double shift
  • The patient died from an air embolism, even though the connection was broken within seconds

Potential for Harm: High

Tips to Reduce Device Misconnections: Identify and manage conditions and practices that may contribute to health care worker fatigue, and take appropriate action

Blood pressure tubing erroneously connected to IV catheter

Blood pressure tubing erroneously connected to IV catheter on mannequin arm.

Case Study 

  • An ER patient had an IV heparin lock but no IV fluids had been started. The patient also had a noninvasive automatic BP cuff placed for continuous monitoring
  • The BP cuff tubing was disconnected when the patient went to the bathroom
  • When she returned, her spouse mistakenly connected the BP cuff tubing to the IV catheter and approximately 15 mL of air was delivered to the IV catheter
  • The patient died from a fatal air embolus, despite resuscitation efforts

Potential for Harm: High

Tips to Reduce Device Misconnections: Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions

IV tubing erroneously connected to nasal cannula

IV tubing erroneously connected to nasal cannula on a mannequin in a hospital bed.

Case Study 

  • A nurse’s aide inadvertently connected a patient’s IV tubing to the nasal oxygen cannula upon transfer to the step down unit
  • The misconnection was not noted until four hours later, when the patient complained of chest tightness and difficulty breathing
  • The patient was treated for congestive heart failure and survived

Potential for Harm: High

Tips to Reduce Device Misconnections: Recheck connections and trace all patient tubes and catheters to their sources upon the patient’s arrival in a new setting or service as part of the handoff process. Standardize this “line reconciliation” process.

Syringe erroneously connected to trach cuff

Syringe erroneously connected to trach cuff on a mannequin.

Case Study 

  • The patient had both a central line with three ports and a trach tube
  • Medicine intended for the central line was inadvertently injected into the trach cuff
  • The trach cuff was damaged and the medicine entered the patient’s lungs
  • A new trach tube was inserted and the patient survived

Potential for Harm: High

Tips to Reduce Device Misconnections: Always trace a tube or catheter from the patient to the point of origin before connecting any new device or infusion

Enteral feeding tube erroneously connected to ventilator in-line suction catheter

Enteral feeding tube erroneously connected to ventilator in-line suction catheter on a mannequin.

Case Study 

  • A patient’s feeding tube was inadvertently connected to the instillation port on the ventilator in-line suction catheter
  • Tube feeding was delivered into the patient’s lungs
  • The patient died

Potential for Harm: High

Tips to Reduce Device Misconnections: Emphasize the risk of tubing misconnections in orientation and training

Pulsatile anti-embolism stocking erroneously connected to IV heparin lock

Succes Story: PAS pump tubing is now NOT CAPABLE of connecting to IV vascular access devices.

Case Study 

  • A patient admitted for stroke had a pulsatile anti-embolism stocking (PAS) on the left lower extremity and an IV heparin lock in the right ankle
  • The patient was alert and oriented on admission but shortly after was found unresponsive and cyanotic
  • The PAS pump tubing was found connected to the IV heparin lock in the patient’s right ankle
  • The patient died of a massive air embolus

Potential for Harm: High

Tips to Reduce Device Misconnections: Manufacturers should implement “designed incompatibility” as appropriate, to prevent dangerous misconnections of tubes and catheters

IV tubing erroneously connected to enteral feeding tube

IV tubing erroneously connected to enteral feeding tube on a mannequin in hospital bed.

Case Study 

  • A child had both a gastric feeding tube for nutrition and an IV for medicine and hydration
  • When the child’s gown was changed, a family member inadvertently attached the IV tubing to the gastric feeding tube
  • The medicine was delivered through the feeding tube into the stomach
  • There was no patient harm since the event was noted in a timely manner

Potential for Harm: Moderate

Tips to Reduce Device Misconnections: Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions

Foley catheter erroneously connected to NG tube

Foley catheter erroneously connected to NG tube on a mannequin in hospital bed.

Case Study 

  • A patient was found with her Foley catheter disconnected from its drainage bag. One end of the catheter was still in her bladder and the other end was connected to her nasogastric (NG) tube
  • Urine was noted to be flowing into her NG tube
  • The NG tube was connected to suction and more than 300 mL of urine drained
  • The patient’s vital signs were stable and her laboratory results were within normal limits

Potential for Harm: Low

Tips to Reduce Device Misconnections: Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions.

Air-filled syringe for limb tourniquet cuff erroneously connected to introducer sheath

Misconnection: air injected into introducer sheath

Case Study 

  • Before removing the arterial sheath from the radial artery, a clinician mistakenly injected air into the arterial sheath instead of into the air inflation port for the tourniquet cuff.
  • Air was injected directly into the patient’s radial artery.
  • The patient suffered a stroke from the air embolism.

Potential for Harm: High

Tips to Reduce Device Misconnections: Emphasize the risk of catheter misconnections in orientation and training, and confirm during every procedure that the correct port is being used for an air injection.

Incorrect dialysate canister mix-up during hemodialysis therapy

Incorrect dialysate canister mix-up during hemodialysis therapy

 

Case Study 

  • A patient was receiving hemodialysis (HD) therapy when it was noted:
    • The citric acid disinfectant canister was erroneously connected to the dialysate line instead of the intended bicarbonate dialysate; and
    • The bicarbonate dialysate was erroneously connected to the disinfectant solution canister instead of the citric acid disinfectant canister.
  • The mix-up of these treatment canisters has the potential to result in electrolyte and/or acid-base imbalance, both of which may lead to serious patient injury or death.
  • During treatment, the patient became unstable with low blood pressure and general distress. Despite discontinuing the treatment, the patient’s status deteriorated, and the patient died before the end of the treatment.

Potential for Harm: High

Tips to Reduce Device Misconnections: To help prevent or minimize cross-connections or use of mismatched concentrates:

  • Follow and conduct a safety check for every treatment, every time.
  • Develop and use a system of labeling connector types and matching containers. This includes checking to make sure the proper connections of dialysates are completed prior to starting therapy.
  • Measure conductivity and pH to ensure delivery of the proper composition of the dialysate.

Air inflation line from noninvasive vascular diagnostic system erroneously connected to IV catheter

Air inflation line from noninvasive vascular diagnostic system erroneously connected to IV catheter

Case Study

  • A technician in training inadvertently connected the air inflation line from a peripheral vascular diagnostic system to a patient’s intravenous (IV) saline lock, instead of to the blood pressure cuff.
  • Pressurized air was injected directly into the patient’s IV.
  • The error was recognized when the blood pressure cuff was not inflating. 
  • The patient suffered a cardiac arrest and died from an air embolus.
  • The connector for the blood pressure cuff was compatible with the Luer connector used on the IV tubing. This permitted a connection between the air inflation tubing and the IV tubing.  The international voluntary consensus standard IEC 80369-5:2016 was published in March 2016 to provide specifications for the connectors used with blood pressure cuffs so that they do not misconnect with other connectors to prevent this type of event. 

Potential for Harm: High

Tips to Reduce Device Misconnections: 

  • Emphasize the risk of IV tubing misconnections in orientation and training
  • Do not purchase non-intravenous equipment with connectors that can physically connect to or attach with a female IV line connector
  • Manufacturers should implement “designed incompatibility” as appropriate, to prevent dangerous misconnections of tubes and catheters
     
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