BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENBREL SURECLICK PF AUTOINJECTOR

    MDR report key: 12861928 · Received November 22, 2021

    Report

    Report Number
    MW5105533
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 15, 2021
    Report Date
    November 19, 2021
    Manufacturer
    AMGEN INC. / IMMUNEX CORPORATION
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS: PATIENT REPORTED THAT 2 OF THE 4 PENS IN HIS SHIPMENT FROM (B)(6) 2021 DID NOT WORK CORRECTLY. WHEN HE WENT TO INJECT THE DOSE, THE NEEDLE WENT INTO SKIN, BUT NO MEDICATION CAME OUT. THE NEEDLE DID NOT RETRACT AFTER REMOVING FROM SKIN. CONFIRMED WITH PATIENT THAT THE WHITE CAP WAS REMOVED BEFORE INJECTING. THE PATIENT MISSED TWO DOSES DUE TO THIS FAILURE. REFERRED PATIENT TO THE MANUFACTURER (B)(4). REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755809 ENBREL SURECLICK PF AUTOINJECTOR INJECTOR, PEN NSC AMGEN INC. / IMMUNEX CORPORATION 1133524
    1755810 ENBREL SURECLICK PF AUTOINJECTOR INJECTOR, PEN NSC AMGEN INC. / IMMUNEX CORPORATION 1133524

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male