BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D 3ML 23G NEEDLE

    MDR report key: 232478 · Received July 15, 1999

    Report

    Report Number
    MW1016761
    Event Type
    Malfunction
    Date Received
    July 15, 1999
    Date of Event
    July 7, 1999
    Report Date
    July 15, 1999
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM MFR ON 10/25/1999: THE PACKAGING MACHINE FOR THIS PRODUCT IS EQUIPPED WITH TWO AUTOMATIC INSPECTION STATIONS WHICH SENSE SYRINGES WITH MISSING NEEDLE/SHIELDS AND PREVENTS THEM FROM BEING LOADED INTO THE PACKAGES. THE EFFECTIVENESS OF THIS DEVICE IS AUDITED DURING EACH SHIFT THE MACHINE IS OPERATED. IN ADDITION, A FINISHED PRODUCT AUDIT IS CONDUCTED ON A WEEKLY BASIS. THE LATTER AUDITS CONFIRM THAT THIS DEFECT OCCURS VERY INFREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-D 3ML 23G NEEDLE SYRINGE FMF BECTON DICKINSON & CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO