BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 1040331 · Received March 14, 2008

    Report

    Report Number
    1040331
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 14, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING THE IV, NURSE FELT SOME RESISTANCE AND REMOVED THE ANGIOCATH. IT WAS NOTICED THAT THE ANGIO TIP HAD SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD CATHETER, IV, SAFETY FOZ BECTON DICKINSON * 7324911

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR