BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX13.5 CE MAHURKAR

    MDR report key: 2443385 · Received January 19, 2012

    Report

    Report Number
    1317749-2012-00023
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 29, 2011
    Report Date
    January 5, 2012
    Manufacturer
    COVIDIEN
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT RING-SHAPED CRACKS WERE OBSERVED AROUND THE Y-SHAPED JOINT OF THE PULSE DIAGNOSIS END AND BLOOD LEAKAGE OCCURRED. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 11.5FX13.5 CE MAHURKAR DIALYSIS CATHETER LFJ COVIDIEN 8813817009 016117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK