BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24955739 · Received April 22, 2026

    Report

    Report Number
    1710034-2026-00451
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    February 6, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826230
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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 THE NEEDLE PIERCED THE CATHETER. CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) WAS INSERTING BD 22G INSYTE AUTOGUARD BC WINGED IV CATHETER. IT WAS REPORTED THAT THE NEEDLE "SPLIT" THE CATHETER. UPON GEMBA WALK INSPECTION THE NURSE HAD RETRACTED THE NEEDLE AND DISPOSED OF THE NEEDLE DEVICE, LEAVING ONLY THE PLASTIC CATHETER FOR INSPECTION AFTER TAKING PHOTOS OF THE DEVICE. IT APPEARED THE NEEDLE HAD PUNCTURED THE SIDE OF THE CATHETER, RATHER THAN SPLIT IT. NURSE DENIED MANIPULATING THE NEEDLE DURING INSERTION. NO HARM TO PATIENT, SMALL BRUISE FROM BLOWN SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015278 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4338236 00382903826230

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male