BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40KT VT

    MDR report key: 1208395 · Received October 16, 2008

    Report

    Report Number
    1317749-2008-00170
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 3, 2008
    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 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 PALINDROME DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE PATIENT GOT INFECTED AFTER PLACING THE PALINDROM SAPPHIRE. PALINDROME WAS PLACED RIJ THE PREVIOUS MONTH, AND REMOVED THIRTEEN DAYS LATER, PATIENT HISTORY, ELEVEN DAYS LATER, ARROW CANNON PLACED LIJ. PATIENT HAS HAD A HISTORY OF TUNNELED CATHETER EXCHANGES. (FIVE MONTHS PRIOR TO ORIGINAL DATE, ARROW CANNON REMOVED). APPROX A MONTH PRIOR TO ORIGINAL DATE, PATIENT HAS ARTHROSCOPIC SHOULDER SURGERY. POST SURGERY, PATIENT COMPLAINED ABOUT SHOULDER PAIN. FIVE DAYS LATER(THE FOLLOWING MONTH), CULTURED FOR INFECTION. ANOTHER FIVE DAYS LATER, PATIENT SEPTIC. UNDETERMINED WHEN THE INFECTION WAS AFFIRMED. PALINDROME WAS REMOVED AND NINETEEN DAYS LATER, ARROW CANNON WAS PLACED LIJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME SAPPHIRE 23/40KT VT DIALYSIS CATHETER MPB COVIDIEN 8888145048 821550

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN