BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW SWAN NCK COIL-CTH LEFT KIT

    MDR report key: 1493534 · Received August 13, 2009

    Report

    Report Number
    1317749-2009-00192
    Event Type
    Malfunction
    Date Received
    August 13, 2009
    Date of Event
    June 1, 2009
    Report Date
    July 21, 2009
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 07/21/2009 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS PATIENT HAD PERITONEAL DIALYSIS CATHETER PLACED ON (B) (6) 2009; ON (B) (6), MD NOTICED SMALL LEAK OF DIALYSATE INTERNALLY INTO TUNNEL WITH DROP OF FLUID EXPRESSED OUT OF EXIT SITE. X-RAYS WERE NEGATIVE FOR AN IDENTIFIED BREAK IN CATHETER. ON (B) (6) 2009, CATHETER NOTED TO BE NON-FUNCTIONING. PATIENT RETURNED TO SURGERY ON (B) (6) FOR CATHETER REMOVAL, WHICH WAS NOTED TO BE DIVIDED JUST ABOVE 2ND INFLAMMATORY BUTTON. PATIENT REQUIRED ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW SWAN NCK COIL-CTH LEFT KIT PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 8888413823 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK