BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-Z COIL SPECIAL (OZ C CA2)

    MDR report key: 867840 · Received June 20, 2007

    Report

    Report Number
    1317749-2007-00055
    Event Type
    Malfunction
    Date Received
    June 20, 2007
    Date of Event
    March 13, 2007
    Report Date
    May 14, 2007
    Manufacturer
    TYCO CANADA
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THERE WAS LEAKAGE ON THE DISTAL CUFF OF THE PD-CATHETER. BECAUSE OF THIS; POSSIBLE PERITONITIS. REMOVAL OF PERITONEAL DIALYSIS CATHETER AND IMPLANTATION OF THE SINGLE LUMEN LONG TERM CHEMO DIALYSIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-Z COIL SPECIAL (OZ C CA2) DIALYSIS CATHETER FJS TYCO CANADA 8888425710 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR