BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC CV CATHETERS (WHITE ADAPTER)

    MDR report key: 13009721 · Received December 15, 2021

    Report

    Report Number
    13009721
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BARD ACCESS SYSTEMS, INC. 6.6F BROVIAC SINGLE LUMEN CATHETER WAS PLACES AND REPAIR TWO MONTHS AFTER. CHEST X-RAY (CXR) SHOWED REPAIR INTACT. FAMILY BROUGHT PATIENT INTO THE EMERGENCY DEPARTMENT (ED) TO EVALUATE POSITIONING AFTER LINE WAS CAUGHT ON CAR SEAT AS PATIENT GOT OUT AND IT LATER BECAME DIFFICULT TO FLUSH. CXR IN ED SHOWED THAT THE TIP REMAINED IN GOOD POSITION BUT REPAIR SITE SHOWED TRANSVERSE LATENCY WITHOUT STENT. REPAIR STENT APPEARS TO HAVE MIGRATED TO ~1.5CM FROM WHERE LINE ENTERS THE SKIN, REQUIRING LINE TO BE SURGICALLY REPLACED. THE STENT COMES FROM THE MANUFACTURER PERMANENTLY ATTACHED TO THE REPAIR SECTION OF THE REPAIR KIT, AND THE SLEEVE SLIDES OVER THE REPAIR SITE AND IS GLUED IN PLACE. WHILE THE FAMILY ORIGINALLY CAME IN WITH THE HISTORY OF THE LINE BEING CAUGHT IN A CAR SEAT, FOR THE STENT TO MIGRATE TO THE POSITION IT WAS IN, IT WOULD HAVE FIRST HAD TO BECOME DISLODGED FROM THE MANUFACTURER'S ATTACHMENT POINT WITHOUT THE REPAIR SITE SEPARATING AND THEN TRAVEL 14CM TOWARD THE PATIENT WITHIN 3.5 HOURS. IT'S ALSO HELD TOGETHER BY GLUE OUTSIDE THE LINE. BETWEEN THE LAYERS OF THE EXTERNAL CATHETER AND INTERNAL LUMEN OF THE REPAIR SLEEVE. THERE IS LITTLE, IF ANY GLUE THAT IS IN CONTACT WITH THE STENT AND THEREFORE A PULLING FORCE WOULD PUT SHEARING FORCE ON THE GLUE OF THE REPAIR BETWEEN THE LAYERS, AND NOT ON THE STENT ITSELF. UNKNOWN LOT NUMBER AT TIME OF REPAIR, CURRENT LOT NUMBER IN HOUSE IS REFQ0276.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907030 BROVIAC CV CATHETERS (WHITE ADAPTER) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. 0601620

    Patients

    Seq Age Sex Outcome Treatment
    1 1825 DA Male Other