BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR KIT 13.5FRX16CM CE

    MDR report key: 2914148 · Received December 7, 2012

    Report

    Report Number
    1317749-2012-00323
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 13, 2012
    Manufacturer
    COVIDIEN
    Product Code
    NIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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 ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATED THE CATHETER HAD MULTIPLE SLIT HOLES IN IT. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR KIT 13.5FRX16CM CE DIALYSIS CATHETER NIE COVIDIEN 8888135162 207510X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK