BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAS-CATH SOFT-CELL 12.5 FR X 23 CM DIALYSIS CATHETER

    MDR report key: 1132444 · Received August 21, 2008

    Report

    Report Number
    3006260740-2008-00081
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 31, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LFJ
    PMA / PMN Number
    K871488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK IS CONFIRMED. UPON RECEIPT OF A PARTIAL TEAR IN THE CATHETER WAS IDENTIFIED AND IS AT THE DISTAL END OF THE BIFURCATION SITE. A CROSS SECTIONAL VIEW OF THE PARTIAL TEAR SHOWS A JAGGED IRREGULAR AND GRANULAR VENEER. THE BREAK LINE IS PERPENDICULAR WITH THE CENTRAL AXIS OF THE TUBING. HOWEVER, THE EXACT MECHANISM OF DAMAGE CANNOT BE DETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS FUNCTIONAL AND ACTUAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. THE CATHETER WAS IN PLACE FOR APPROXIMATELY 25 DAYS PRIOR TO THE COMPLAINT INCIDENT. A CHR OF LOT #RERI0267 SHOWED NO OTHER PRODUCT COMPLAINTS FROM THE LOT NUMBER.

    Description of Event or Problem · 1

    LEAKAGE FROM 3 TO 4 CM ABOVE THE CUFF. FOUND 25 DAYS AFTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAS-CATH SOFT-CELL 12.5 FR X 23 CM DIALYSIS CATHETER LFJ C. R. BARD INC. (BASD) RERI0267

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention