BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAH ELITE IC 12FR 20CM SE

    MDR report key: 3982601 · Received July 24, 2014

    Report

    Report Number
    3009211636-2014-00026
    Event Type
    Other
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 9, 2014
    Manufacturer
    COVIDIEN MANUFACTURING SOLUTIONS SA
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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)(6) 2014, THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STES THAT THE MAHURKAR ELITE CATHETERS HAVE CLOTTED IN 3 CRRT PATIENTS. TWO OF THE PATIENTS HAD TO HAVE THE CATHETER EXCHANGED OUT 3 TIMES. ONE PATIENT HAD TO RECEIVE BLOOD THINNERS DUE TO THE CLOTTING. THERE WAS NO CHANGE TO THE HOSPITAL STAFF'S DIALYSIS CATHETER PROTOCOL. CUSTOMER BELIEVES THAT THE MATERIAL ON THE MAHURKAR ELITE IS DIFFERENT THAT THE ORIGINAL MAHURKAR CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435364 MAH ELITE IC 12FR 20CM SE DIALYSIS CATHETER MSD COVIDIEN MANUFACTURING SOLUTIONS SA 8888221320 319935X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK