BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 1381035 · Received May 11, 2009

    Report

    Report Number
    1381035
    Event Type
    Malfunction
    Date Received
    May 11, 2009
    Date of Event
    April 27, 2009
    Report Date
    April 30, 2009
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV CATHETER INSERTED WITHOUT PROBLEM, GOOD BLOOD FLUSH BACK, NORMAL SALINE FLUSH, WHILE FLUSHING HUB OF CATHETER CRACKED AND UNABLE TO USE. REMOVED AND RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BECTON DICKINSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES| NO OTHER THERAPIES