BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UF 30G 1/2 CC SYRINGE

    MDR report key: 1082220 · Received July 25, 2008

    Report

    Report Number
    1920898-2008-00021
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED FROM THE END OF 2007 STARTED EXPERIENCING NEEDLE BREAK OFF DURING INJECTION. CONSUMER HAD ONE NEEDLE REMOVED AT THE HOSP AT THE END OF 2007, AND ANOTHER NEEDLE REMOVED IN 2008. CONSUMER STATED THAT HER BLOOD GLUCOSE APPEARED TO BE UNDER CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UF 30G 1/2 CC SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R