BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED TRIFUSION CATHETER

    MDR report key: 3042964 · Received March 7, 2013

    Report

    Report Number
    3006260740-2013-00094
    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 PARTIAL CRACK IN THE BLUE COMPRESSION CLAMP IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS OF THE CATHETER SHOW A PARTIAL CRACK IN THE BLUE COMPRESSION CLAMP. THE PARTIAL CRACK IS LOCATED ON ONE OF THE ARMS OF THE BLUE CLAMP. THE CRACK IS <0.1 INCHES IN LENGTH. RESIDUAL MATERIAL IS SEEN ALONG THE LENGTH OF THE CRACK. AT THIS TIME THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPE EXAMINATIONS OF THE COMPLAINT SAMPLE SHOWS 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. 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 BLUE CLAMP WAS NOTED TO BE CRACKED AND CLOSE TO BREAKING. IT WAS DECIDED TO HAVE THE CATHETER REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98491 IMPLANTED TRIFUSION CATHETER LONG TERM INTRAVASCULAR CATHETER LJS C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention