BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25148262 · Received May 12, 2026

    Report

    Report Number
    1710034-2026-00504
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. 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 THERE WAS FOREIGN MATTER ON THE CATHETER. "GOOD MORNING, ONE OF OUR NURSES OPENED AN IV CATHETER AND NOTICED THAT THERE WAS SOMETHING INSIDE THE CAP. I TOOK IT OUT AND IT SEEMS TO HAVE WHAT LOOKS LIKE A PLASTIC STRING ON THE TIP AND AT THIS TIME WE HAVE NOT FOUND ANYMORE, PLEASE SEE PICTURES BELOW." CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 27-04-2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200273 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6049763 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown