BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE-PRO EDGE SAFETY DEVICE

    MDR report key: 2003512 · Received February 22, 2011

    Report

    Report Number
    MW5019509
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEEDLE-PRO EDGE SAFETY DEVICE INSULIN SYRINGE MFG BY SMITH MEDICAL ASD, INC. WHEN ACTIVATING SAFETY CAP THE NEEDLE BENDS COMING THROUGH SAFETY CAP CAUSING A NEEDLE STICK TO NURSE. THIS HAS RESULTED IN 3 EMPLOYEES BEING EXPOSED TO BLOOD/BODY FLUIDS THROUGH NEEDLESTICKS IN THE LAST 10 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE-PRO EDGE SAFETY DEVICE INSULIN SYRINGE FMI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1