BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBECTA AUTOSHIELD DUO

    MDR report key: 22412360 · Received July 7, 2025

    Report

    Report Number
    MW5172272
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 1, 2025
    Manufacturer
    EMBECTA MEDICAL II LLC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INSULIN NEEDLE (NEEDLE PORTION ONLY) FOUND LEFT IN INSULIN PEN. PEN DISPOSED OF, NEW PEN SECURED. IN REVIEW, BELIEVE THAT SAFETY DEVICE PORTION WAS REMOVED WITHOUT THE NEEDLE BEING REMOVED FROM THE PEN WITH THE SAFETY. NEEDLE IS EMBECTA AUTOSHIELD DUO, SIZE 0.30 MM X 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204583 EMBECTA AUTOSHIELD DUO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC SIZE 0.30 MM X 5

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male