BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 8 MM PEN NEEDLE

    MDR report key: 1679000 · Received May 7, 2010

    Report

    Report Number
    9616656-2010-00006
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    March 12, 2010
    Report Date
    May 7, 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

    EVAL SUMMARY: SEVEN SEALED AND INTACT 31G X 8MM OPEN NEEDLES WERE RETURNED FROM LOT NO. 7152118, CAT NO. 320563. EACH SAMPLE WAS EXAMINED CAREFULLY AND THERE WAS SUFFICIENT ADHESIVE BONDING FOR THE NEEDLE TO THE POST AREA OF THE HUB. THE DEVICE HISTORY REVIEW SHOWS THE PRODUCT WAS MFG MID JULY 2007 WITH 610 NEEDLE PULL TEST PERFORMED, ALL WERE ABOVE THE MINIMUM PULL FORCE. NO DEFECTS WERE FOUND DURING MANUFACTURE. NO FURTHER ACTION.

    Description of Event or Problem · 1

    THE NEEDLE BROKE IN THE MUSCLE OF THE PT'S ARM DURING INJECTION. THERE WAS A SURGERY WITH GENERAL ANESTHESIA, BUT THE NEEDLE IS STILL IN THE ARM NEXT TO THE RADIAL NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 8 MM PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 7152118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention