BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD 31G 1/2 CC SYRINGE

    MDR report key: 1063146 · Received June 20, 2008

    Report

    Report Number
    1920898-2008-00018
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 20, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 REVIEW AS LOT NUMBER IS UNKNOWN. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED CANNULA OF ONE OF HER INSULIN SYRINGES BROKE OFF IN HER STOMACH. CONSUMER DID SEE MD WHO CLEANED THE SITE WITH ALCOHOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD 31G 1/2 CC SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention