BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 28/45KT VT

    MDR report key: 3843569 · Received February 11, 2014

    Report

    Report Number
    1317749-2014-00074
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    October 10, 2013
    Report Date
    January 31, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    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 ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THEY OBSERVED LEAKAGE FROM A CRACK IN CATHETER. THE CATHETER WAS IMPLANTED IN THE RIGHT INTERNAL JUGULAR VEIN. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90651 PALINDROME SAPPHIRE 28/45KT VT DIALYSIS CATHETER MSD COVIDIEN 8888145049C 107799

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR