BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAS-CATH SOFT-CELL KIT 12.5 F X 23CM [PRE-CURVED LONG TERM D

    MDR report key: 1963747 · Received December 22, 2010

    Report

    Report Number
    3006260740-2010-00386
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 29, 2010
    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 PARTIAL BREAK IS CONFIRMED. UPON RECEIPT A PARTIAL TEAR IN THE CATHETER WAS IDENTIFIED AND IS LOCATED AT THE DISTAL END OF THE SURECUFF AND CATHETER TUBING. A CROSS SECTIONAL VIEW OF THE PARTIAL TEAR SHOWS A JAGGED IRREGULAR AND GRANULAR VENEER. THE BREAK LINE IS NEARLY PERPENDICULAR WITH THE CENTRAL AXIS OF THE TUBING; HOWEVER AT THIS TIME THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS FUNCTIONAL AND TACTUAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THE CATHETER WAS IN PLACE FOR APPROXIMATELY 656 DAYS PRIOR TO THE COMPLAINT INCIDENT. A CHR OF LOT #RESI0324 SHOWED OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    CATHETER BREAK WAS FOUND. THE INDWELLING PERIOD WAS 656 DAYS. THE DEVICE WAS INSERTED VIA THE RIGHT INTERNAL JUGULAR VEIN. AT FIRST, THE DEVICE WAS USED WITHOUT ANY PROBLEMS. THEN THE BLOOD SAMPLE DATA GATHERED DURING HEMODIALYSIS STATED SHOW ABNORMAL ERRORS. FURTHERMORE, BECAUSE PERIODICAL X-RAY CHECK FOR THE DEVICE INDICATED A POSSIBLE CATHETER BREAK NEAR THE SURE CUFF, IMAGING TEST WAS PERFORMED. WHEN CONTRAST AGENT WAS INFUSED INTO ONE LUMEN, THE AGENT LEAKED INTO ANOTHER SIDE OF LUMEN AND THE AGENT WAS INFUSED INTO BOTH LUMEN OF CATHETER LOCATING DISTAL TO THE SURE CUFF. THE USER SUSPECTED A MALFUNCTION OF THE DEVICE AND REMOVED THE CATHETER. AFTER ITS REMOVAL, THE CATHETER BREAK WAS CONFIRMED AND THE BREAK SITE WAS LOCATED NEAR THE SURE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAS-CATH SOFT-CELL KIT 12.5 F X 23CM [PRE-CURVED LONG TERM D LFJ C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention