BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF CATH (10)

    MDR report key: 4240900 · Received November 10, 2014

    Report

    Report Number
    3009211636-2014-00150
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 9, 2014
    Manufacturer
    COSTA RICA
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS NOT PROVIDED. WITHOUT THE LOT NUMBER, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITHOUT THE SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A CONFIRMED ROOT CAUSE OF THIS ISSUE. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATED THAT THE DOCTOR CONDUCTED INTUBATION ON (B)(6) 2014, AND CHANGED THE PERITONEAL DIALYSATE ON (B)(6) 2014. ON THE EVENING OF (B)(6) 2014, THE RELATIVES OF THE PATIENT FOUND THAT THERE WAS LEAKAGE IN THE MIDDLE OF EXIT OF PERITONEAL DIALYSIS CATHETER UNDER THE SKIN AND THE TITANIUM JOINT. THEN THE NURSE ASSISTED THE DOCTOR IN USING 3M STERILE ADHESIVE TAPE TO TEMPORARILY PACKED IT. AT 11 AM, (B)(6), THE DOCTOR CUT OFF THE DAMAGED CATHETER. AFTER STERILIZING THE CATHETER, THE DOCTOR RECONNECTED THE TITANIUM JOINT AND THE EXTERNAL SHORT CATHETER. THEN USE OF PENICILLIN WHOLE DAY TO PREVENT INFECTION. ON (B)(6) 2014, THE PATIENT LEFT HOSPITAL. THERE WAS NO LEAKAGE DURING THE PATIENT'S STAY AT HOME, UNTIL (B)(6) 2014 WHEN THE PATIENT WAS HOSPITALIZED DUE TO PERITONITIS. ON (B)(6) 2014, THE PATIENT WAS CURED AND LEFT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722842 TENCKHOFF CATH (10) DIALYSIS CATHETER FJS COSTA RICA 8888423103 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization