BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBECTA AUTOSHIELD DUO INSULIN PEN NEEDLE

    MDR report key: 22997124 · Received September 8, 2025

    Report

    Report Number
    MW5175745
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 4, 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

    PLACED NEEDLE ON LANTUS INSULIN PEN AND WAS ABLE TO PRIME NEEDLE WITHOUT DIFFICULTY. WHEN DIALED IN LANTUS INSULIN DOSE, MED WAS DIFFICULT TO PUSH AND WHEN REMOVED NEEDLE, FOUND PORTION OF NEEDLE WAS RETAINED IN THE INSULIN PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407551 EMBECTA AUTOSHIELD DUO INSULIN PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male