BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1061154 · Received June 11, 2008

    Report

    Report Number
    1061154
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BD INFUSION THERAPY SYSTEM, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    FLASH OF BLOOD OBSERVED IN HUB UPON INSERTION. ENTIRE NEEDLE ADVANCED. AT THAT TIME IT WAS NOTED THAT NO PLASTIC CATHETER WAS ATTACHED TO THE GREEN HUB. CATHETER WAS NOT IN THE PACKAGE AND WAS MISSING ENTIRELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED IV CATHETER CATHETER, IV FOZ BD INFUSION THERAPY SYSTEM, INC. * 8011121

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR