BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DY

    MDR report key: 1893683 · Received November 2, 2010

    Report

    Report Number
    1317749-2010-00298
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Report Date
    October 20, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/1/2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 10/20/2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS A PALINDROME EMERALD CATHETER PLACED ON (B)(6) 2010, DEVELOPED A HOLE IN THE EXTENSION NEAR THE HUB. CATHETER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DY HEMODIALYSIS CATHETER FJS COVIDIEN UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK