BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD U-F II 3/10CC 31G INSULIN SYRINGE

    MDR report key: 992806 · Received February 8, 2008

    Report

    Report Number
    1920898-2008-00001
    Event Type
    Injury
    Date Received
    February 8, 2008
    Date of Event
    January 16, 2007
    Report Date
    February 8, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY CHECK AS LOT NUMBER IS UNKNOWN. WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTS USING SYRINGE AND NEEDLE BROKE OFF IN BODY. INDICATED THAT EVENT OCCURRED ABOUT ONE (1) YEAR AGO AND CONSUMER WENT TO DOCTOR TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD U-F II 3/10CC 31G INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention