BEUDAMED
    FDA Adverse Event Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 2767488 · Received September 5, 2012

    Report

    Report Number
    2767488
    Date Received
    September 5, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    AT IV TEAM MEETING, SOME HOSPITALS REPORTED A LARGER NUMBER OF IV CATHETER PROBLEMS THAN USUAL. I ASKED SOME NURSES TO SAVE THE IV CATHETERS IF THEY WERE GETTING A BLOOD RETURN AND THE IV "BLEW" WHEN THREADING INTO VEIN. TODAY, 2 CATHETERS IN 2 BIOHAZARD BAGS WERE LEFT FOR ME WITH A NOTE THAT STATED BOTH IVS "BLEW" AFTER HAD A GOOD BLOOD RETURN. LOT # 2174521 (2 IN ONE BAG) AND # 2160691 (2 IN ANOTHER BAG).UNKNOWN WHO LEFT THE CATHETERS, MESSAGE OR WHICH PATIENTS THEY WERE USED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC FOZ BECTON DICKINSON * 2174521
    2 INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC FOZ BECTON DICKINSON * 2160691

    Patients

    Seq Age Sex Outcome Treatment
    1 *