BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5FR X 13.5CM MAHURKAR KIT

    MDR report key: 2961014 · Received January 15, 2013

    Report

    Report Number
    1317749-2013-00036
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 8, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES AFTER USING FOR APPROXIMATELY THREE MONTHS, THE CATHETER ADAPTER CRACKED. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23270 11.5FR X 13.5CM MAHURKAR KIT DIALYSIS CATHETER MPB COVIDIEN 8813817005 023812

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK