BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN NECK COIL CATH CA2 LEFT

    MDR report key: 3982931 · Received July 14, 2014

    Report

    Report Number
    3009211636-2014-00008
    Event Type
    Other
    Date Received
    July 14, 2014
    Date of Event
    December 2, 2013
    Report Date
    June 26, 2014
    Manufacturer
    COSTA RICA, COVIDIEN MANUFACTURING
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH DIALYSIS CATHETER. THE CUSTOMER STATES THAT A PT RETURNED TO THE HOSPITAL IN (B)(6) 2013. THE PT WAS ADMITTED DUE TO PERITONITIS WHEN IT WAS DISCOVERED THAT HER PD CATHETER HAD A FRACTURE/BREAK. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE. INITIAL PLACEMENT OF THE CATHETER WAS (B)(6) 2005 AND THERE WERE NO SIGNS OF PERITONITIS THROUGHOUT THE 8 YEARS OF PD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410214 SWAN NECK COIL CATH CA2 LEFT DIALYSIS CATHETER MSD COSTA RICA, COVIDIEN MANUFACTURING 8888413807 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening