BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31G 5MM 3/16 UF

    MDR report key: 23680141 · Received December 1, 2025

    Report

    Report Number
    MW5179573
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Report Date
    November 24, 2025
    Manufacturer
    EMBECTA MEDICAL II LLC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT A LOT OF THE NEEDLES SHE GETS ARE DEFECTIVE, IT'S EITHER THE TIPS IS CROOKED, OR IT'S BENT AND IT HURTS WHEN SHE'S HAVING TO INJECT HERSELF. NO MISSED DOSE OR ADVERSE EVENTS REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. INDICATION: AGE-REL OSTEOPOR W AGE-RELATED OSTEOPOROSIS WITH CURRENT PATHOLOGICAL FRACTURE, UNSPECIFIED SITE, 7THD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078974 PEN NEEDLE 31G 5MM 3/16 UF NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female TERIPARATIDE PEN (TEVA).