BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 511447 · Received February 4, 2004

    Report

    Report Number
    MW1031097
    Event Type
    Malfunction
    Date Received
    February 4, 2004
    Date of Event
    January 28, 2004
    Report Date
    February 4, 2004
    Manufacturer
    BD MEDICAL SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV CATHETER WOULD NOT RETRACT AT FIRST AND RN ALMOST LOST IV STICK. FINALLY RETRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD SHIELDED IV CATHETER FOZ BD MEDICAL SYSTEMS 20 GA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other