BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 2340887 · Received November 10, 2011

    Report

    Report Number
    2340887
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 10, 2011
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    THE SAFETY MECHANISM ON THE BD INSYTE AUTOGUARD IS NOT WORKING; WHEN THE BUTTON IS PUSHED, THE NEEDLE DOES NOT RETRACT. THIS ISSUE HAS BEEN NOTED ON AT LEAST TWO DEVICES FROM LOT# 1140531. THERE WERE NO PATIENT INJURIES REPORTED. THE FACILITY IS WORKING WITH THE LOCAL REPRESENTATIVE REGARDING REPLACEMENT OF IMPACTED LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD SHIELDED IV CATHETER FOZ BECTON DICKINSON AND COMPANY * 11450531

    Patients

    Seq Age Sex Outcome Treatment
    1 *