MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER ENFIT CONNECTORS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This is a report of a generally unsafe situation, no error happened.Our health system sometimes provides care for patients who present with a duopa pump.This pump has tubing which is leur compatible.Our health system has switched to exclusive use of iso 80369-3 connectors (enfit ).We are concerned that a wrong-route error could occur with this product and have reached out to abbvie regarding this.They responded that the specialty pharmacies can dispense an adaptor allowing the patient to connect their enfit tubing with the current duopa pump.While this is true, and we can also provide such an adaptor, we strongly encourage abbvie to update their product to the current standard.When these patients are within an acute care inpatient setting the risk of wrong route administration is higher.As we did not get the response we were hoping for from abbvie, we are reporting this to ismp in the hope that you will reach out to the manufacturer as well.Thank you for your attention.(b)(6).

• Brand Name: ENFIT CONNECTORS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER
• MDR Report Key: 19060689
• MDR Text Key: 339715711
• Report Number: MW5153633
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: DUOPA PUMP