BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 2771375 · Received September 13, 2012

    Report

    Report Number
    2771375
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Date of Event
    July 18, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BECTON DICKSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TECH PLACED AN 18 GAUGE NEXIVA IV IN THE PATIENT'S RIGHT FOREARM AND WAS PROCEEDING TO DRAW LABS FROM THE IV. IN THE PROCESS OF DRAWING LABS, THE TECH NOTICED THAT THE AIR WAS BEING DRAWN IN TO THE BLOOD TUBES. UPON COMPLETING THE BLOOD DRAW THE PATIENT NOTICED LEAKING OF THE BLOOD FROM THE RUBBER STOPPER AT THE NEEDLE EXIT SITE. WHEN THE TECH FLUSHED THE IV WITH NORMAL SALINE 10ML, THERE WAS PRONOUNCED LEAKING OF BLOOD AND SALINE FROM THE SAME SITE. IV WAS REMOVED IMMEDIATELY FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D FOZ BECTON DICKSON INFUSION THERAPY SYSTEMS, INC. * 2097873

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR