BEUDAMED
    FDA Adverse Event Summary report: N

    EXTERNAL CATHETER SEGMENT FOR HICKMAN 7 FR PED

    MDR report key: 2222678 · Received July 25, 2011

    Report

    Report Number
    3006260740-2011-00257
    Date Received
    July 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 6, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF CATHETER BREAKAGE IS CONFIRMED. RETURNED FOR EVALUATION IS THE REPAIR SECTION OF A HICKMAN 7 FR CATHETER. THE CATHETER EXHIBITED ONE PARTIAL TEAR JUST AT THE DISTAL END OF THE BIFURCATION SITE. THE TEAR IS PARTIAL AND DOES NOT CIRCUMVENT THE CIRCUMFERENCE OF THE TUBING. ONLY THE OUTER TUBING EXHIBITS A TEAR. THE INTERMEDIATE TUBING IS UNREMARKABLE UNDER MICROSCOPIC EXAMINATION. NO BLUNT INSTRUMENT TRAUMA OR CLAMPING DAMAGE WAS OBSERVED ASSOCIATED WITH THE TEAR SITE. IT APPEARS THE TUBING HAS BEEN STRETCHED BEYOND ITS ELASTIC LIMITS; HOWEVER, THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED AT THIS TIME. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS, FUNCTIONAL AND TACTUAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TOT HE MANUFACTURING PROCESS. CARE MUST BE EXERCISED WHEN IMPLANTING, DRESSING, MAINTAINING AND REMOVING THE CATHETER IN ORDER TO AVOID DAMAGE TO THE DEVICE. A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFORMATION HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    DAMAGED CATHETER WAS FOUND. THE INDWELLING PERIOD WAS 90 DAYS. THE CATHETER WAS INSERTED THOUGH THE RIGHT SUBCLAVIAN VEIN FOR WEEKLY TPN AND CHEMOTHERAPY TREATMENT. PRE AND POST FLUSHES ARE PERFORMED FOR EACH TREATMENT. A PARTIAL SLIT WAS FOUND ON THE CATHETER NEAR THE BIFURCATION SITE. THE PATIENT IS VERY ACTIVE AND THERE IS THE POSSIBILITY THAT THE PATIENT HAS PULLED THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL CATHETER SEGMENT FOR HICKMAN 7 FR PED LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention