BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12FR X 13CM TRIPLE MAH CE, TRAY

    MDR report key: 1953873 · Received November 30, 2010

    Report

    Report Number
    1317749-2010-00320
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 4, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS WHEN USING CONTINUOUS VENO-VENOUS DIALYSIS (CVVD) ON A PATIENT, THE STAFF COULD NOT GET THE CONNECTOR OFF OF THE TUBING TO THE CVVD MACHINE. THE CVVD TUBING BROKE. LATER THAT DAY, THEY HAD THE SAME DIFFICULTY WITH THE CONNECTOR AND THE CATHETER CONNECTION (ADAPTER) BROKE. THE CATHETER NEEDED TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12FR X 13CM TRIPLE MAH CE, TRAY HEMODIALYSIS CATHETER MSD COVIDIEN 8888101001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR