BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR 13.5FRX13.5CM PC KIT

    MDR report key: 2652411 · Received June 29, 2012

    Report

    Report Number
    1317749-2012-00140
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Report Date
    June 13, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/28/2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 06/13/2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THERE IS A HOLE IN THE MATERIAL OF THE DIALYSIS CATHETER. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR 13.5FRX13.5CM PC KIT DIALYSIS CATHETER MSD COVIDIEN 8888135133 33717

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR