BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR 13.5FRX24CM CE KIT

    MDR report key: 3843539 · Received February 11, 2014

    Report

    Report Number
    1317749-2014-00076
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 31, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE ARTERIAL ADAPTER OF THE CATHETER WHICH WAS IMPLANTED 2 WEEKS AGO, HAD A CRACK. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90505 MAHURKAR 13.5FRX24CM CE KIT DIALYSIS CATHETER MPB COVIDIEN 8888135242 217312X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK