BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW SWAN NCK COIL-CTH LEFT KIT

    MDR report key: 920577 · Received October 1, 2007

    Report

    Report Number
    1317749-2007-00082
    Event Type
    Malfunction
    Date Received
    October 1, 2007
    Date of Event
    July 9, 2007
    Report Date
    September 24, 2007
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATED THAT A PT WOKE UP ALL WET BECAUSE THE CATHETER WAS CUT. THE BALANCE OF THE CATHETER WAS REMOVED IN SURGERY. PT WAS TREATED AS PHOPHYLAXIS FOR PERITONITE. PT STATUS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW SWAN NCK COIL-CTH LEFT KIT DIALYSIS CATHETER MSD TYCO HEALTHCARE/KENDALL 8888413823 621907

    Patients

    Seq Age Sex Outcome Treatment
    1 YR