BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 3792610 · Received March 25, 2014

    Report

    Report Number
    3792610
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    NEXIVA 20G IV TUBING SPLIT IN 1/2 DURING INJECTION, WHILE PRESSURIZED INJECTION WAS BEING ADMINISTERED. DEVICE WOULD HAVE "KICKED OFF" IF PRESSURE WAS OUTSIDE SAFE PRESSURE FOR DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173741 BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR