BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40SP VT

    MDR report key: 1203310 · Received October 14, 2008

    Report

    Report Number
    1317749-2008-00164
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    October 1, 2008
    Report Date
    September 26, 2008
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/09/2008. 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 A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE ULTEM ADAPTERS WERE CRACKED AND THE CATHETER WAS EXCHANGED FOR A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME SAPPHIRE 23/40SP VT DIALYSIS CATHETER MPB COVIDIEN 8888123409 723103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN