BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE 31G 5MM 3/16 UF

    MDR report key: 23077662 · Received September 17, 2025

    Report

    Report Number
    MW5176214
    Event Type
    Injury
    Date Received
    September 17, 2025
    Report Date
    September 13, 2025
    Manufacturer
    EMBECTA MEDICAL II LLC
    Product Code
    FMI
    Adverse Event
    Yes
    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 ON HER PEN NEEDLES. SHE STATED WHEN SHE INJECTS, SHE HAS A BLACK AND BLUE SPOT ON HER SKIN AND SHE HAD DIFFICULTY WITH THE NEEDLE PENETRATING HER SKIN AND THE LIQUID LEAKED OUT ON THE TOP OF HER. SHE WANTED THE BD PEN NEEDLES SHE PREVIOUSLY HAD BUT ADVISED IT IS NO LONGER AVAILABLE AND ADVISED WE CAN REPLACE THE BOX AS IT MAY BE A BAD BATCH. PATIENT VERIFY AND UNDERSTAND (V/U). TERIPARATIDE: THE PRODUCT LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. NO ADDITIONAL DATES, INFORMATION, OR DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577543 PEN NEEDLE 31G 5MM 3/16 UF NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC 320882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female TERIPARATIDE.| UNKNOWN DRUG AS NECESSARY.