BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT

    MDR report key: 18539508 · Received January 18, 2024

    Report

    Report Number
    1710034-2024-00020
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 25, 2023
    Report Date
    February 5, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK COULD NOT BE CONFIRMED FROM THE 5 REPRESENTATIVE 20G NEXIVA UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #3234047. A FUNCTIONAL TEST REVEALED NO LEAKS IN ANY OF THE RETURNED CATHETERS. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. INVESTIGATION CONCLUSION(S): THE REPORTED DEFECT ¿LEAKAGE¿ COULD NOT BE CONFIRMED. PROBABLE ROOT CAUSE CONCLUSION(S): A ROOT CAUSE CANNOT BE DETERMINED IN THE ABSENCE OF A CONFIRMED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 GAUGE IV CATHETER WAS INSERTED INTO PATIENT. UPON REMOVING THE NEEDLE TO THE SAFETY POSITION, THE CATHETER BEGAN TO LEAK RESULTING IN REMOVING THE IV FROM PATIENT DUE TO IT NO LONGER FUNCTIONING PROPERLY. THIS PATIENT WAS A HARD POKE AND HAD ALREADY HAD ONE FAILED ATTEMPT AT AN IV PLACEMENT. NO PATIENT INJURY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406290 BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234047 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown