BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, PISTON

    MDR report key: 22529620 · Received July 16, 2025

    Report

    Report Number
    MW5172817
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    July 13, 2025
    Report Date
    July 13, 2025
    Manufacturer
    BD / BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OPENED A STERILE PACKAGED SYRINGE BARREL FROM BD AND THE SYRINGE IS DIRTY. DISCOVERED AFTER I PUT THE MEDICATION FOR MY RARE GENETIC DISEASE IN IT. RESULTED IN LOSS OF MY DOSAGE OF MEDICINE. MY MEDICINE REQUIRES PRIOR AUTHORIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807603 SYRINGE, PISTON SYRINGE, PISTON FMF BD / BECTON DICKINSON SEE PICTURES SEE PICTURES

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female STRENSIQ.