BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR 11.5FR STRAIGHT CATH

    MDR report key: 3003642 · Received February 12, 2013

    Report

    Report Number
    1317749-2013-00072
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 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

    SUBMIT DATE: (B)(4) 2013. 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 AIR AND BLOOD LEAKAGE OCCURRED ON THE BLUE VENOUS END DURING DIALYSIS. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61314 MAHURKAR 11.5FR STRAIGHT CATH DIALYSIS CATHETER MPB COVIDIEN 8830415001 128733X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK