BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF CATH T202

    MDR report key: 2913882 · Received December 6, 2012

    Report

    Report Number
    1317749-2012-00313
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 5, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 CATHETER WAS INSERTED IN (B)(6) 2012. LEAKAGE WAS OBSERVED OUTSIDE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENCKHOFF CATH T202 DIALYSIS CATHETER FJS COVIDIEN 8888411405 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK