BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED TRIFUSION CATHETER

    MDR report key: 3042966 · Received March 7, 2013

    Report

    Report Number
    3006260740-2013-00093
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A BREAK IN THE RED COMPRESSION CLAMP IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS SHOW A COMPLETE BREAK IN ONE OF THE ARMS OF THE RED COMPRESSION CLAMP. THE BREAK SITE IS LOCATED AT THE APEX OF THE UPPER CURVE OF THE CLAMP. A CROSS SECTIONAL VIEW OF THE BREAK SITE REVEALS A DULL AND GRANULAR VENEER. AT THIS TIME THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THIS MAY BE A USER MAINTENANCE ISSUE. NO OTHER COMPLICATIONS WITH THIS DEVICE ARE KNOWN. THIS IMPLIES THE DEVICE FUNCTIONED AS DESIGNED UNTIL THE COMPLAINT INCIDENT OCCURRED. NO MANUFACTURING DEFECTS WERE OBSERVED WITH THE CATHETER. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. 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

    OUTPATIENT ARRIVED TO OUR DEPARTMENT (B)(6) 2013 FOR HIS SCHEDULED BIWEEKLY PROCEDURE. THE RED CLAMP WAS REPORTED BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98354 IMPLANTED TRIFUSION CATHETER LONG TERM INTRAVASCULAR CATHETER LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention