BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 21142529 · Received January 13, 2025

    Report

    Report Number
    1710034-2025-00011
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 18, 2024
    Report Date
    March 5, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835195
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF LEAKING FROM THE END NEAR THE GREEN WINGS AND A BLOWN IV COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 18G NEXIVA DEVICES THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #4232063. A FUNCTIONAL TEST AND MICROSCOPIC EXAMINATION REVEALED NO DAMAGE OR DEFECTS ON THE RETURNED SAMPLES. THE AFFECTED UNITS WERE NOT RETURNED FOR INVESTIGATION. 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. A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE MODE OF LEAKAGE AT THE SEPTUM AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTIFY THE ROOT CAUSE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST PLACED AN 18G R AC. I GOT THE IV NO PROBLEM BUT THEN BLOOD STARTED LEAKING/GUSHING OUT OF THE END NEAR THE GREEN WINGS. I REMOVED THE IV. IT RESULTED IN THE PATIENT BEING POKED A TOTAL OF 3 TIMES SINCE THE SECOND IV BLEW. (THE FIRST ONE WOULD HAVE BEEN FINE EXCEPT THE FAULTY IV). ITEMS WERE NOT SAVED FOR SENDING BACK DUE TO THE AMOUNT OF BLOOD COVERING MY HANDS AND THE IV SYSTEM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486247 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4232063 00382903835195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown