BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN NECK COIL CATH CA2 LEFT

    MDR report key: 3204239 · Received June 26, 2013

    Report

    Report Number
    1317749-2013-00190
    Event Type
    Other
    Date Received
    June 26, 2013
    Date of Event
    December 2, 2012
    Report Date
    May 28, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    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 (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE PD CATHETER WAS PLACED ON (B)(6) 2007, POSITIONED IN THE RIGHT MIDDLE QUADRANT. ON (B)(6) 2012, A HOME PATIENT NOTIFIED THE STAFF AT DAVITA DIALYSIS THAT THE DIALYSIS THAT THE CATHETER WAS LEAKING BECAUSE OF A HOLE IN THE CATHETER. A STAFF MEMBER OBSERVE THE HOLE IN THE CATHETER AT THE POINT WHERE THE BETA CAP ADAPTER COMES INTO CONTACT WITH THE INNER PART OF THE PD CATHETER. THE PATIENT WAS SENT FOR LAB TESTING. LABS RESULTS FROM (B)(6) 2013 DID CONFIRM THAT THIS PATIENT DID HAVE PERITONITIS AND WAS TREATED WITH ANTIBIOTICS AND HOSPITALIZED. DATES OF HOSPITALIZATION WERE NOT PROVIDED. THE CATHETER WAS REMOVED ON (B)(6) 2013. A NEW PD CATHETER WAS PLACED ON (B)(6) 2013 IN THE RIGHT LOWER QUADRANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290601 SWAN NECK COIL CATH CA2 LEFT DIALYSIS CATHETER FJS COVIDIEN 8888413807 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R