BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR MAXID

    MDR report key: 2040030 · Received March 25, 2011

    Report

    Report Number
    1317749-2011-00110
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    March 18, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    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 HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE MAHURKAR MAXID CATHETER 19 CM DEVELOPED A HOLE, UNDER THE CLAMPS. CATHETER HAS BEEN IN PLACE LESS THAN 6 WEEKS. CATHETER HAD TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR MAXID HEMODIALYSIS CATHETER FJS COVIDIEN UNKNOWN DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK