BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE LL 3ML 1/LOML GRAD EA BD HOSPITAL DIVISION

    MDR report key: 10553089 · Received September 17, 2020

    Report

    Report Number
    MW5096729
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 1, 2020
    Report Date
    September 15, 2020
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SYRINGE KEPT GETTING STUCK AND WAS REALLY HARD TO PUSH. PATIENT DID NOT MISS A DOSE OR EXPERIENCE AN ADVERSE EVENT AS A RESULT OF THE MALFUNCTION. DEFECTIVE PRODUCT LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. PATIENT DOES NOT HAVE DEFECTIVE PRODUCT ON HAND BECAUSE IT WAS USED AND DISCARDED. REPORTED TO (B)(6) BY PT/ CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011907 SYRINGE LL 3ML 1/LOML GRAD EA BD HOSPITAL DIVISION SYRINGE, PISTON FMF ALLISON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR