BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURL CATH 62CM 2 CUFF

    MDR report key: 2123621 · Received June 10, 2011

    Report

    Report Number
    1317749-2011-00180
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/10/2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS, THE PT BEGAN PERITONEAL DIALYSIS IN 2005. THE PT NOTED LEAKAGE OF THE PERICATHETER ON (B)(6) 2011. A HOLE WAS LATER DETECTED ABOUT 1CM FROM THE SKIN EXIT OF THE PD CATHETER. CATHETER REQUIRED REMOVAL AND WILL BE REPLACED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURL CATH 62CM 2 CUFF PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 8811313010 150677

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR