BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 380259 · Received March 4, 2002

    Report

    Report Number
    MW1024244
    Event Type
    Malfunction
    Date Received
    March 4, 2002
    Date of Event
    February 2, 2002
    Report Date
    February 20, 2002
    Manufacturer
    BD MEDICAL SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV CATHETER INSERTED INTO PT. PT COMPLAINED OF PAIN. AFTER RETRACTION OF CATHETER FROM PT, NOTED THAT PLASTIC TIP WAS BENT UPWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD IV CATHETER FOZ BD MEDICAL SYSTEMS 381433 112032

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other