BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 1324174 · Received February 23, 2009

    Report

    Report Number
    1710034-2009-00031
    Event Type
    Other
    Date Received
    February 23, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 4, 2006
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - A ROOT CAUSE ANALYSIS COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. THE DEVICE HISTORY WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MANUFACTURE. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE PT WAS A DIFFICULT STICK AND SO THE PICC RN CRNI WAS CALLED. THE INSERTION WAS SUCCESSFUL, AND THEN STARTED THE BLOOD DRAW. SHE USED VACUTAINER TUBES DIRECTLY FROM BD Q-SYTE WITH THE COVIDIEN ANGEL WING LUER LOCK ADAPTER. AFTER THE NURSE DREW THE BLOOD FOR LAB AND CULTURES, SHE THOUGHT THE IV CLOTTED. SHE COULD SEE BLOOD IN THE HUB AREA OF THE CATHETER. WHEN SHE TRIED TO FLUSH WITH NORMAL SALINE, THE SALINE SPRAYED OUT OF THE OPPOSITE BD Q-SYTE AND ALL OVER HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CLOSED IV ACCESS SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 8051673

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other