BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40KT VT

    MDR report key: 1488483 · Received August 12, 2009

    Report

    Report Number
    1317749-2009-00186
    Event Type
    Malfunction
    Date Received
    August 12, 2009
    Report Date
    July 21, 2009
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 07/21/2009, THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. CUSTOMER STATES THAT THIS CATHETER ADAPTOR CRACKED AND THE CATHETER HAD TO BE PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME SAPPHIRE 23/40KT VT DIALYSIS CATHETER MPB COVIDIEN 8888145048 822911

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK