BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER PLUS SAFETY NEEDLE

    MDR report key: 2021526 · Received March 15, 2011

    Report

    Report Number
    2021526
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 10, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE WAS REMOVED FROM PATIENT'S PORT AND PLACED ON TABLE. THE NEEDLE POPPED OUT OF THE SAFETY POSITION. AFTER IT POPPED OUT OF THE SAFETY POSITION, IT COULD NOT BE CLICKED INTO THE SAFE POSITION FOR PROTECTION. IT COULD HAVE POKED THAT STAFF MEMBER OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS SAFETY NEEDLE PORT ACCESS SAFETY NEEDLE FMI SMITHS MEDICAL 31-2767-24 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *