BEUDAMED
    FDA Adverse Event Injury Summary report: N

    29 GA PEN NEEDLE

    MDR report key: 1153291 · Received September 8, 2008

    Report

    Report Number
    9616656-2008-00008
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. IF PRODUCT IS RECEIVED, EVALUATION WILL BE CONDUCTED. COMPLAINT HISTORY CHECK RUN ON THE LOT INDICATED YIELDED 5 ADDITIONAL COMPLAINTS FOR UNRELATED ISSUES. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    PATIENT HAD NEEDLE BREAK IN HIS STOMACH AREA. PATIENT WENT TO THE EMERGENCY ROOM TO HAVE THE NEEDLE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 29 GA PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 7123558

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention