BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UF 29G 1/2CC INSULIN SYRINGE

    MDR report key: 1031219 · Received April 14, 2008

    Report

    Report Number
    1920898-2008-00007
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 29, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 INSULIN SYRINGE CANNULA BROKE OFF IN STOMACH ON SATURDAY. CONSUMER INDICATED A MEDICAL ATTENTION WAS SOUGHT, HAD X-RAY OF THE NEEDLE AND SHE IS HAVING SURGERY ON FRIDAY APRIL 4TH TO HAVE NEEDLE REMOVED FROM HER STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UF 29G 1/2CC INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention