BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN NECK TNCKHOFF SN T2 LFT

    MDR report key: 2313275 · Received October 11, 2011

    Report

    Report Number
    1317749-2011-00279
    Event Type
    Malfunction
    Date Received
    October 11, 2011
    Date of Event
    September 25, 2011
    Report Date
    October 3, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS ON (B)(6) 2011, A NEW HOLE WAS FOUND ON THE CATHETER. AS CORRECTIVE ACTION THE CATHETER WAS CUT JUST ABOVE THE HOLE, THE TITANIUM PORT WAS REPLACED AND 1GR OF VANCOMYCIN GIVEN TO THE PATIENT FOR PREVENTION OF INFECTION. AFTER THE SEVERAL REDUCTIONS MADE, THE LENGTH OF THE CATHETER WAS 1CM FROM THE SKIN. ON (B)(6) 2011 A REPAIR KIT WAS USED IN THE OPERATING ROOM TO RECOVER THE CATHETER LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN NECK TNCKHOFF SN T2 LFT PERITONEAL DIALYSIS CATHETER MPB COVIDIEN 8888412007 162029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN