BEUDAMED
    FDA Adverse Event Other Summary report: N

    IN SWN NCK CRL CATH 39.1CM 2CF

    MDR report key: 2969499 · Received February 12, 2013

    Report

    Report Number
    1317749-2013-00070
    Event Type
    Other
    Date Received
    February 12, 2013
    Report Date
    January 23, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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 PERITONEAL DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER WAS PLACED ON (B)(6) 2012 AND TWO HOLES DEVELOPED AND BOTH WERE REPAIRED. THE PT WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61658 IN SWN NCK CRL CATH 39.1CM 2CF PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 8888413100 6417

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other