BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER PLUS

    MDR report key: 3193363 · Received June 20, 2013

    Report

    Report Number
    MW5030653
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    DELTEC, SMITH MEDICAL ASD, INC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GRIPPER NEEDLE'S SAFETY MECHANISM DID NOT ENGAGE. THE NEEDLE APPEARED SLIGHTLY BENT AND RETRACTED BEYOND THE BORDERS CAUSING AN EMPLOYEE TO BE STUCK BY THE NEEDLE. A SECOND GRIPPER NEEDLE WAS OPENED AND AGAIN THE SAFETY FEATURE DID NOT ENGAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281486 GRIPPER PLUS 22GX1" GRIPPER PLUS NEEDLE FMI DELTEC, SMITH MEDICAL ASD, INC 33X342

    Patients

    Seq Age Sex Outcome Treatment
    1