BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIPPER MICRO NEEDLE

    MDR report key: 1772172 · Received July 23, 2010

    Report

    Report Number
    2183502-2010-00320
    Event Type
    Injury
    Date Received
    July 23, 2010
    Report Date
    July 21, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FPA
    PMA / PMN Number
    K072059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: DEVICE HAS BEEN RETURNED FOR EVALUATION BUT THE EVALUATION IS NOT COMPLETE AT THIS TIME. WHEN THE EVALUATION IS COMPLETE, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING NEEDLESTICK INJURY THAT OCCURRED AT THE USER FACILITY. AT THE CONCLUSION OF AN INFUSION THE NURSE ATTEMPTED TO ACTIVATE THE SAFETY FEATURE OF THE DEVICE. THE NURSE CAUGHT HER GLOVE IN THE HINGE OF THE DEVICE, WHILE ATTEMPTING TO EXTRICATE HER GLOVE THE DEVICE BROKE, THE NEEDLE REBOUNDED AND SHE WAS STUCK IN THE FINGER. THERE WAS NO REPORT OF INCIDENT RELATED MEDICAL SEQUELAE AND NO TREATMENT WAS REPORTED. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER MICRO NEEDLE FPA- SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD (FORMERLY DELTEC, INC) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention