BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF CATH (10)

    MDR report key: 3982922 · Received July 14, 2014

    Report

    Report Number
    3009211636-2014-00010
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 29, 2025
    Manufacturer
    COSTA RICA, COVIDIEN MANUFACTURING
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 STATES THAT THE CATHETER WAS INSERTED IN THE PT'S BODY ON (B)(6) 2013. DURING A REGULAR PERITONEAL DIALYSIS PROCEDURE A MONTH LATER, IT WAS FOUND THAT THE PT'S APPLICATOR AND CLOTHING WAS SOAKED. AFTER CHECK, THE NURSE FOUND A SMALL CRACK ON THE CATHETER. THE CLINICIAN THEN USED 502 SUPER ADHESIVE GLUE TO REPAIR THE CATHETER CRACK. THE PT WAS DISCHARGED. IN (B)(6) 2014, THE PT'S FAMILIES REPAIRED THE CATHETER WITH 502 SUPER GLUE ADHESIVE AGAIN. THE PT WAS ADMITTED FOR PERITONITIS. ON (B)(6) 2014, THE PT RETURNED THE FACILITY AND THE CLINICIAN FOUND THE PERITONEAL DIALYSATE WAS MUDDY. THE PT WAS HOSPITALIZED AGAIN FOR A PERITONITIS INFECTION. THE PT WAS GIVEN A PRESCRIPTION AND RECOVERED WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410213 TENCKHOFF CATH (10) DIALYSIS CATHETER FJS COSTA RICA, COVIDIEN MANUFACTURING 8888423103 225006X

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Life Threatening| H