BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.2 F BROVIAC CV CATHETERS, 0.7 MM LUMEN

    MDR report key: 2161272 · Received July 4, 2011

    Report

    Report Number
    2161272
    Event Type
    Malfunction
    Date Received
    July 4, 2011
    Date of Event
    June 11, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BROVIAC STOPPED WORKING IN THE EMERGENCY ROOM. WHEN PATIENT ARRIVED TO THE FLOOR, NURSE TRIED TO FLUSH IT. IT FLUSHED. IN THE MIDDLE OF FLUSHING, THE BROVIAC MADE A POPPING NOISE AND THEN THE TUBING BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.2 F BROVIAC CV CATHETERS, 0.7 MM LUMEN CATHETER, CENTRAL VENOUS LJS BARD ACCESS SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO