BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 3003820 · Received March 7, 2013

    Report

    Report Number
    3003820
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER LINE WAS PLACED, RN WAS ATTEMPTING TO SECURE CAP TO THE END OF THE PLASTIC "Y" WHEN IT CRACKED LEAKING BLOOD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PERIPHERAL LINE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96740 BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. * 2165792

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR