BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN NECK COIL CATH CA2 LEFT

    MDR report key: 3264927 · Received July 25, 2013

    Report

    Report Number
    1317749-2013-00241
    Event Type
    Other
    Date Received
    July 25, 2013
    Date of Event
    April 22, 2013
    Report Date
    July 1, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER STARTED LEAKING AT THE CATHETER PORT, WHICH RESOLVED IN RELEASING DIALYSATE, RESULTING IN PERITONITIS. THE CATHETER HAS BEEN SURGICALLY REMOVED, AND PRESCRIBED ANTIBIOTICS FOR THE PERITONITIS AND 6 WEEKS OF DIALYSIS. FOR THE PURPOSE OF HEMODIALYSIS THE PHYSICIAN MADE AN ADD'L ENTRANCE IN THE STOMACH. WHEN PT RECOVERS FROM INFLAMMATION AND THE SURGERY, THERE WILL BE A NEW CATHETER PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349250 SWAN NECK COIL CATH CA2 LEFT DIALYSIS CATHETER FJS COVIDIEN 8888413807 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other