BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 19/36SP

    MDR report key: 1182017 · Received September 26, 2008

    Report

    Report Number
    1317749-2008-00151
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 15, 2008
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. DIALYSIS CLINICAL NURSE SPECIALIST, SAID SHE FEELS THIS MAY BE DUE TO THE INTERESTING PHYSICIANS NOT BURYING THE CUFF DEEP ENOUGH IN THE TUNNEL TRACK.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT PATIENT WAS BROUGHT INTO IR IN 2008 TO EXCHANGE CATHETER BECAUSE IT HAD FALLEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME SAPPHIRE 19/36SP DIALYSIS CATHETER MPB COVIDIEN 8888119369 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK