BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN NECK TNCKHOFF SN T2 LFT

    MDR report key: 2313257 · Received October 11, 2011

    Report

    Report Number
    1317749-2011-00278
    Event Type
    Malfunction
    Date Received
    October 11, 2011
    Date of Event
    August 28, 2011
    Report Date
    October 3, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    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 COVIDIENT ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER ADAPTER. THE CUSTOMER REPORTS A PATIENT CAME TO THE HOSPITAL ON (B)(6), 2011, AND IT WAS OBSERVED THAT THE TITANIUM PORT WAS MISSING. A NEW TITANIUM PORT WAS PUT IN PLACE COUPLED WITH AN INJECTION OF LGR OF VANCOMYCIN AS PREVENTIVE THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN