BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENBREL

    MDR report key: 881661 · Received July 15, 2007

    Report

    Report Number
    MW5003029
    Event Type
    Malfunction
    Date Received
    July 15, 2007
    Date of Event
    July 15, 2007
    Report Date
    July 15, 2007
    Manufacturer
    IMMUNEX CORPORATION AKA AMGEN INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I FOUND A DEFECTIVE 27-GAUGE 1/2 INCH NEEDLE IN THE ENBREL DOSE TRAY -LOT NUMBER D082694-. THE PLASTIC PIECE THAT IS USED TO ATTACH THE NEEDLE TO THE SYRINGE CONTAINED TWO NEEDLES, ONE OF WHICH WAS BENT BACKWARDS. I DID NOT NOTICE THE SECOND NEEDLE UNTIL I PRESSED ON THE SYRINGE PLUNGER, AT WHICH POINT SEVERAL DROPS OF THE MEDICATION LEAKED FROM THE SYRINGE INSTEAD OF BEING INJECTED UNDER MY SKIN AS INTENDED. THIS IS THE THIRD TIME THIS CALENDAR YEAR THAT I HAVE FOUND A DEFECTIVE NEEDLE IN AN ENBREL DOSE TRAY. IN THE FIRST INSTANCE, THERE WAS ONLY ONE NEEDLE, BUT IT WAS WEDGED IN THE OUTSIDE OF THE PLASTIC PIECE THAT IS USED TO CONNECT THE NEEDLE TO THE SYRINGE, SO THAT NO LIQUID COULD BE DISPENSED FROM THE SYRINGE. IN THE SECOND CASE, THE PLASTIC PIECE CONTAINED TWO NEEDLES, ONE OF WHICH WAS ATTACHED TO THE OUTSIDE OF THE PLASTIC PIECE. I DO NOT RECALL THE LOT NUMBERS FOR MEDICATION CONTAINING THE EARLIER DEFECTIVE NEEDLES. PLEASE NOTE THAT EACH DOSE TRAY THAT I RECEIVE INCLUDES ONLY ONE NEEDLE COMPONENT, SO THAT I AM FACED WITH THE LOSS OF ACCESS TO A DOSE, UNLESS I SAVE AND REUSE A SYRINGE FROM ANOTHER DOSE TRAY, A COURSE OF ACTION THAT IS NOT RECOMMENDED BY ANY MEDICAL ADVICE I HAVE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENBREL ENBREL DOSAGE TRAY FMI IMMUNEX CORPORATION AKA AMGEN INC. D082694

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other