BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 6 80X10

    MDR report key: 2023140 · Received February 15, 2011

    Report

    Report Number
    2953724-2011-00006
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER, CONTINUOUS FLOW. THE CUSTOMER REPORTS THAT DURING A DIALYSIS FISTULA THROMBOLYSIS, THE END OF THE TRELLIS 6 CATHETER BROKE OFF. DR (B)(6) HAD TO SNARE THE END OF THE CATHETER THAT BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 6 80X10 CATHETER, CONTINUOUS FLOW KRA COVIDIEN BVT608010 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN