BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31G 5MM 3/16 UF

    MDR report key: 24431292 · Received February 24, 2026

    Report

    Report Number
    MW5184322
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Report Date
    February 19, 2026
    Manufacturer
    EMBECTA MEDICAL II LLC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: INBOUND CALL FROM PATIENT REPORTED PEN NEEDLES BEING DEFECTIVE - PATIENT WAS UNABLE TO ATTACH THEM ONTO THE PEN. THESE ARE THE SAME KIND OF PEN NEEDLES SHE RECEIVED IN THE PAST, BUT THIS TIME UNABLE TO USE. PEN NEEDLE 31G 5MM 3/16 UF LOT # 5071014, EPX 03/31/2030. DIAGNOSIS FOR USE: OSTEOPOROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499694 PEN NEEDLE 31G 5MM 3/16 UF NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC 83017088203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female TYMLOS PF PEN.