BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH'S PORTEX NEEDLE-PRO EDGE SAFETY DEVICE WITH

    MDR report key: 819212 · Received February 8, 2007

    Report

    Report Number
    MW1041935
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    February 6, 2007
    Report Date
    February 8, 2007
    Manufacturer
    SMITH'S MEDICAL ASD, INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO INJECT MEDICATION INTO A JOINT. THE PLUNGER GAVE SOME RESISTANCE, THEN THE NEEDLE AND HUB DETACHED FROM THE SYRINGE, MEDICATION SPRAYED ON THE PT. NEEDLE USED: 25G 1 1/2", REF # 4293, LOT# K679161 OR K50074, UNSURE AS TO WHICH LOT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH'S PORTEX NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE FMF SMITH'S MEDICAL ASD, INC * 1041908

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR