BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25230054 · Received May 20, 2026

    Report

    Report Number
    1710034-2026-00539
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835195
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    I WAS REPORTED THAT LEAKAGE OCCURRED. UPON REPORT FROM THE IV TECH, UPON INSERTION OF THE IV, BLOOD LEAKED FROM THE CONNECTION AREA WHERE THE NEEDLE IS SUPPOSED TO BE REMOVED FROM. THE IV HAD TO BE REMOVED AND A NEW IV PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388770 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4156831 00382903835195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown