BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE 31G 8 MM 5/16 SHRT

    MDR report key: 23169154 · Received September 29, 2025

    Report

    Report Number
    MW5176736
    Event Type
    Injury
    Date Received
    September 29, 2025
    Report Date
    September 24, 2025
    Manufacturer
    EMBECTA MEDICAL II LLC.
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED HAVING TROUBLE WITH THE PEN NEEDLE 31G 8 MM 5/16 SHORT STATED THE NEEDLES ARE TOO LONG AND CAUSING TO BLEED MORE. NO FURTHER INFORMATION, DATES, OR DETAILS REPORTED. INDICATION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146287 PEN NEEDLE 31G 8 MM 5/16 SHRT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC. 320881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female TYMLOS PF PEN