BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 5MM PEN NEEDLE

    MDR report key: 2011662 · Received March 3, 2011

    Report

    Report Number
    9616656-2011-00011
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 12, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 DURING INJECTION IN THE LEFT THIGH, STARTED TO FEEL THE MEDICATION COMING OUT. WHEN CONSUMER PULLED OUT THE PEN, THERE WAS NO NEEDLE. THE NEEDLE BROKE OFF IN THE LEFT THIGH. 24 HOUR NURSE LINE ADVISED HER TO GO TO THE EMERGENCY ROOM WHERE X-RAY WAS TAKEN AND BECAUSE THE NEEDLE WAS TOO SMALL AND COULD NOT BE FOUND, CONSUMER HAD TO SEE ORTHOPEDIC SURGEON AND SCHEDULE APPOINTMENT. MEANTIME, KEFLEX 500 MG WAS PRESCRIBED TO PREVENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 5MM PEN NEEDLE NEEDLE, HYPODERMINC, SINGLE LUMEN FMI BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention