BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25137109 · Received May 11, 2026

    Report

    Report Number
    1710034-2026-00497
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    February 23, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    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

    IT WAS REPORTED THAT FOREIGN MATTER WAS NOTED ON A NEEDLE. "NWWI HAS AN ISSUE WITH A LOT CONTAINING BLACK/METALLIC LOOKING COATING ON THE INSIDE PACKING OF THE STERILE NEEDLES. XXXXX HAS THESE NEEDLES SET ASIDE AND NEEDS INFORMATION TO SEND THEM BACK TO YOU FOR INVESTIGATION AND REPLACEMENT." "BLACK/METALLIC LOOKING COATING ON THE NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153796 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5274574 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown