BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSHIELD DUO

    MDR report key: 24589504 · Received March 13, 2026

    Report

    Report Number
    24589504
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    January 22, 2026
    Report Date
    January 23, 2026
    Manufacturer
    EMBECTA MEDICAL II LLC
    Product Code
    FMI
    UDI-DI
    00383017951535
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE ATTEMPTING TO SCREW NEEDLE ONTO THE END OF THE INSULIN PEN, THE SPRING CAME OUT AND DEVICE FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244963 AUTOSHIELD DUO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC 329515 5226013 00383017951535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other