BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5FR X 13.5 MAHURKAR CATH

    MDR report key: 2030790 · Received March 22, 2011

    Report

    Report Number
    1317749-2011-00100
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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 STATES THE BLUE ADAPTOR GOT BROKEN AND THE CATHETER WAS IN THE PT AT THE TIME. CATHETER WAS PULLED OUT AND IT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.5FR X 13.5 MAHURKAR CATH HEMODIALYSIS CATHETER MSD COVIDIEN 8813816009 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR