BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 1053012 · Received May 15, 2008

    Report

    Report Number
    1053012
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BD INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN 18 GAUGE 1.16 INCH IV CATHETER BEING INSERTED TO LEFT WRIST, NURSE WENT TO ADVANCE CATHETER AND NOTED CATHETER NO LONGER ATTACHED TO HUB. CATHETER APPEARS TO BE IN RETRACTION CHAMBER.====================== MANUFACTURER RESPONSE FOR 18 GAUGE SHIELDED IV CATHETER, BD INSYTE AUTOGUARD======================LOCAL REPRESENTATIVE AVAILABLE ON SITE TO EXAMINE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD CATHETER, IV FOZ BD INFUSION THERAPY SYSTEMS, INC. * 7340858

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NONE KNOWN| NONE KNOWN