BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 8MM PEN NEEDLE

    MDR report key: 1810035 · Received August 12, 2010

    Report

    Report Number
    9616656-2010-00018
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 9, 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
    JA
    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 NUMBER IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    COMPANY REP REPORTED NEEDLE BROKE OFF AND REMAINED IN PT'S ABDOMEN WHEN PARENT GAVE HORMONE INJECTION TO THE PT. THE REMAINING NEEDLE FRAGMENT WAS SUCCESSFULLY RETRIEVED WITH SURGICAL INTERVENTION. IT TOOK APPROX 25 MINS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention