BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRUDUCER

    MDR report key: 2052061 · Received March 1, 2011

    Report

    Report Number
    3006260740-2011-00059
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 9, 2011
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONFIRMED. THE PRODUCT IMPLICATED AND RETURNED FOR EVAL IS A BROVIAC 6.6 FR SINGLE LUMEN CATHETER TUBING. THE TUBING CONTAINS THE SURECUFF. DURING FUNCTIONAL TESTING OF THE CATHETER TWO PINHOLE LEAKS WERE OBSERVED. THE LEAK SITES ARE LOCATED 2.4 INCHES PROXIMAL TO THE SURECUFF. THE LEAK SITES ARE UNDISTINGUISHABLE WHILE UNDER MAGNIFICATION AND ARE ONLY VISIBLE DURING HYDRAULIC PRESSURIZATION. AT THIS TIME THE CAUSE OF THE LEAKS IS UNDETERMINED. THE IFU GIVES INSTRUCTIONS TO AVOID CONTACT WITH SHARP INSTRUMENTS. A CHR OF LOT #HUUC211 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    SUBCUTANEOUS LEAK WAS FOUND. THE INDWELLING PERIOD WAS 7 DAYS. THE CATHETER WAS INSERTED VIA THE RIGHT SUBCLAVIAN VEIN FOR TPN USE. A WEEK AFTER THE CATHETER PLACEMENT, THE TPN INFUSION THOUGH THE CATHETER WAS PERFORMED. HOWEVER, DURING THE INFUSION SUBCUTANEOUS LEAK WAS FOUND AND THE CATHETER WAS REMOVED. THE REMOVED CATHETER HAD A FEW PINHOLES IN AN AREA WHERE WAS LOCATED INSIDE THE PT BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRUDUCER LJS C. R. BARD INC. (BASD) HUUC1211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention