BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 3385810 · Received September 24, 2013

    Report

    Report Number
    1317749-2013-00298
    Event Type
    Other
    Date Received
    September 24, 2013
    Report Date
    June 6, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
    Product Code
    MPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THERE IS A HOLE IN THE QUINTON CATHETER, WHICH CAUSED PERITONITIS. THE PATIENT, A (B)(6) FEMALE WAS HOSPITALIZED ON THE SAME DAY, (B)(6) 2013. THE PERITONEAL EFFLUENT WAS ANALYZED AND THE RESULT WAS LEUOCYTE COUNT 2400 CELLS/MM3, NEUTROPHILS 80% AND LYMPHOCYTES 20%. ON (B)(6) 2013, THE PATIENT WAS TREATED WITH VANCOMYCIN IP 1G EVERY 5TH DAY AND FORTUM IP 250 MG IN EACH EXCHANGE (4 EXCHANGE/DAY). THE PT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482020 DIALYSIS UNKNOWN DIALYSIS CATHETER MPB COVIDIEN LP, FORMERLY REGISTERED AS KENDALL UNKNOWN DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization