BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5 CE MAHURKAR

    MDR report key: 2941717 · Received January 2, 2013

    Report

    Report Number
    1317749-2013-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 2, 2012
    Report Date
    December 12, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    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 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTED THE CATHETER BROKE/SEPARATED AT THE LUMEN. THE CATHETER WAS IMPLANTED ON (B)(6) 2012. IT WAS IN USE FOR (B)(6) BEFORE THE FAILURE OCCURRED. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436 KIT 11.5FX19.5 CE MAHURKAR DIALYSIS CATHETER MSD COVIDIEN 8813793013 204704X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK