BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25321890 · Received May 28, 2026

    Report

    Report Number
    8041187-2026-00014
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K183399; K243403. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    ON THESE IV'S THE SMALL EXTENSION IS PART OF A CLOSED SYSTEM ATTACHED TO THE IV CATHETER WITH WINGS. THE EXTENSION WAS LEAKING SO THE ENTIRE IV HAD TO BE TAKEN OUT AND REPLACED. THIS RENDERED PT'S VEIN UNUSABLE AND ANOTHER POINT OF ACCESS HAD TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243266 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 5170551 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1