BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME RUBY 23/40 SP VT

    MDR report key: 1220782 · Received October 31, 2008

    Report

    Report Number
    1317749-2008-00175
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    COVIDIEN LP
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2008, THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THEY HAD TO REPLACE A PT'S TUNNELED DIALYSIS CATHETER DUE TO A HOLE IN THE SILICONE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME RUBY 23/40 SP VT DIALYSIS CATHETER MPB COVIDIEN LP 8888123408 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK