BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC

    MDR report key: 4251167 · Received November 4, 2014

    Report

    Report Number
    4251167
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    March 24, 2014
    Report Date
    November 4, 2014
    Manufacturer
    C. R. BARD, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT IN THIS REPORT HAS HAD A TOTAL OF 15 BREAKS WITH THE 4.2 FR BROVIAC LINES. LINE REPLACEMENT WAS REQUIRED TO CONTINUE TPN INFUSIONS WITH EACH BREAK. THIS HAS BEEN REPORTED TO THE MANUFACTURER. WE HAVE NOT BEEN ABLE TO IDENTIFY A COMMON CAUSE FOR THE LINE FRACTURES.TO MAKE NOTE, WE BEGAN TRACKING OUR LINE FRACTURES ON BROVIACS. FOLLOWING ARE THE NUMBER OF BREAKS DURING A 12 MONTH PERIOD AT THIS FACILITY, SORTED ACCORDING TO DEVICE SIZE. MULTIPLE PATIENTS WERE INVOLVED. PATIENTS WITH LINE BREAKS REQUIRED AN ADDITIONAL LINE PLACEMENT IN ORDER FOR THEIR THERAPY TO CONTINUE.2.7FR: 12 PLACED, 0 BREAKS4.2FR: 23 PLACED, 18 BREAKS6.6FR: 24 PLACED, 8 BREAKS7.0FR: 18 PLACED, 6 BREAKS====================== MANUFACTURER RESPONSE FOR BROVIAC TUNNELED 4.2 FRENCH SINGLE LUMEN CENTRAL VENOUS LINE, BARD ACCESS SYSTEMS (PER SITE REPORTER)======================SPOKE WITH THE SALES REPRESENTATIVE, HE WAS NOT AWARE OF ANY OTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706729 BROVIAC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 FOZ C. R. BARD, INC. * HUWL1499

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR OTHER