BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC 4.2 FR S/L CENTRAL VENOUS CATHETER

    MDR report key: 1170367 · Received September 10, 2008

    Report

    Report Number
    3006260740-2008-00111
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 9, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONFIRMED, AND SHOULD BE RECORDED AS USER RELATED. THE SPLIT LOCATED ON THE CATHETER TUBING CONTAINS CHARACTERISTICS ASSOCIATED WITH BURST TRAUMA, SECONDARY TO OVER- PRESSURIZATION. IT APPEARS INFUSION PRESSURES HAVE EXCEEDED THE ELASTIC STRENGTH OF THE TUBING DURING INFUSION. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS AND FUNCTIONAL TESTING SHOWED NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A CHR OF LOT #HUSA1680 SHOWED NO OTHER PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    LEAKAGE OCCURRED FROM A HOLE NEAR THE JUNCTURE. FOUND 58 DAYS AFTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC 4.2 FR S/L CENTRAL VENOUS CATHETER LJS C. R. BARD INC. (BASD) HUSA1680

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention