BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF CATH (10)

    MDR report key: 2914166 · Received December 7, 2012

    Report

    Report Number
    1317749-2012-00318
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 13, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE PT HAD THE CATHETER INSERTED ON (B)(6) 2012. THE DIALYSIS CATHETER DROPPED OUT OF HER ABDOMINAL CAVITY ON (B)(6) 2012 AND THE TWO CUFFS WERE REMAINED IN THE PT. THE PT WAS HOSPITALIZED ON (B)(6) 2012. PT WAS GIVEN A SECOND OPERATION TO CHANGE TO ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENCKHOFF CATH (10) DIALYSIS CATHETER FJS COVIDIEN 8888423103 108510X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization