BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31G 5MM 3/16 UF

    MDR report key: 24569806 · Received March 11, 2026

    Report

    Report Number
    MW5185077
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Report Date
    March 9, 2026
    Manufacturer
    EMBECTA MEDICAL II LLC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT'S MOTHER REPORTED LEAKAGE WITH EMBECTA PEN NEEDLE. SHE WOULD BE RECEIVING A HUMATROPE PEN REPLACEMENT FROM MANUFACTURER. UNKNOWN IF MISSED DOSE OCCURRED. NO ADVERSE EVENT REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222782 PEN NEEDLE 31G 5MM 3/16 UF NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC. 5014088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male HUMATROPE CART KIT.