BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25319982 · Received May 28, 2026

    Report

    Report Number
    1710034-2026-00559
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 4, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, IL WAS USED AS THE STATE.

    Description of Event or Problem · 0

    BD INSTYLE AUTOGUARD BC NEEDLE FAILED TO RETRACT AFTER NURSE USED IT ON PATIENT. INFUSION CENTER MANAGER AND CHARGE NURSE RANDOMLY SELECTED ANOTHER FROM THE SAME LOT AND THE RETRACTOR STUCK AGAIN, BUT WITH ADDITIONAL PRESSING FINALLY RETRACTED. ALL NEEDLES WITH THIS LOT# WERE PULLED FROM THE FLOOR AND BACKSTOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164511 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6022552 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1