BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER PLUS POWER P.A.C

    MDR report key: 1902905 · Received October 29, 2010

    Report

    Report Number
    1902905
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 29, 2010
    Manufacturer
    SMITH MEDICAL MD, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE DEACCESSING A PATIENT'S PORT CATHETER, THE DEVICE WAS VERY DIFFICULT TO REMOVE AND REQUIRED PULLING MORE FIRMLY. IT FINALLY CAME OUT, BUT DID NOT RETRACT INTO THE FOAM COVERING RESULTING IN A NEEDLE SLICE TO THE NURSE'S LEFT THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS POWER P.A.C CATHETER, IMPLANTED, PORT LJT SMITH MEDICAL MD, INC. 21-3362 470X38

    Patients

    Seq Age Sex Outcome Treatment
    1 *