BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE

    MDR report key: 18392190 · Received December 22, 2023

    Report

    Report Number
    MW5149493
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Report Date
    December 13, 2023
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS COMMUNICATION FROM PATIENT'S FATHER WHO REPORTED FAULTY PEN NEEDLES. FIRST NEEDLE DUE TO USER ERROR. THE SECOND AND THIRD NEEDLE BROKE UPON RECAPPING AND THE 4TH NEEDLE UPON RECAPPING WENT THROUGH THE CHAMBER AND SHATTERED THE GLASS. UNKNOWN IF PATIENT MISSED ANY DOSES. NO ADVERSE EVENTS REPORTED. UNKNOWN IF PATIENT HAS DEFECTIVE PRODUCT ON HAND. NO ADDITIONAL INFORMATION AVAILABLE. REPORTED TO CVS/CAREMARK BY: PATIENT/CAREGIVER. REFERENCE REPORTS: MW5149492, MW5149494, MW5149495.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291795 PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female GENOTROPIN 2-CHAMBER CART.