BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR 13.5FR X 16CM SE KIT

    MDR report key: 2011736 · Received February 14, 2011

    Report

    Report Number
    1317749-2011-00039
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Report Date
    January 26, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THERE WAS A PIN HOLE IN THE SILICONE EXTENSION OF THE CATHETER; CATHETER NEEDED TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR 13.5FR X 16CM SE KIT HEMODIALYSIS CATHETER MPB COVIDIEN 8888135161 0161124

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK