BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5CM MAHURKAR

    MDR report key: 1972918 · Received January 19, 2011

    Report

    Report Number
    1317749-2011-00015
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 10, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 STATED THERE WAS OOZING BLOOD IN BIFURCATE PLACE OF THE CATHETER TUBE. CATHETER NEEDED TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 11.5FX19.5CM MAHURKAR HEMODIALYSIS CATHETER MPB COVIDIEN 8813793009 008621

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK