BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD 31G X 8MM PEN NEEDLE

    MDR report key: 1810034 · Received August 12, 2010

    Report

    Report Number
    9616656-2010-00017
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 # IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    COMPANY REP REPORTED NEEDLE SNAPPED OFF IN PT'S LEG. THE BROKEN NEEDLE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD 31G X 8MM PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention