BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIPPER PLUS NEEDLE

    MDR report key: 2122968 · Received June 9, 2011

    Report

    Report Number
    2183502-2011-00461
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 20, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FPA
    PMA / PMN Number
    K021999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED FOR EVAL BUT THE EVAL IS NOT COMPLETE AT THIS TIME. WHEN THE EVAL IS COMPLETE, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    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 ACTIVATED THE SAFETY FEATURE OF THE DEVICE. THE DEVICE WAS NOT CAPTURED AND THE NURSE WAS STUCK BY THE EXPOSED NEEDLE. THE CLINICIAN IS BELIEVED TO BE RECEIVING MEDICAL TREATMENT CONSISTENT WITH BLOOD EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS NEEDLE FPA - SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 21-2968 832X39

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention