BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/SLOT

    MDR report key: 982142 · Received January 22, 2008

    Report

    Report Number
    1317749-2008-00011
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    October 12, 2007
    Report Date
    January 2, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL IN EARLY 2008 THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. CUSTOMER REPORTS: "A PALINDROME CATHETER FELL OUT OF THE PT IN LATE 2007. THERE WAS NO PULLING ON THE CATHETER, THERE WAS NO INFECTION AND NO INFLAMMATION. THIS SPECIFIC COMPLAINT IS FROM A MALE, WHO IS NOT OBESE. THE CATHETER WAS A RIGHT IJ INSERTION IN 2006. THE CATHETER FELL OUT IN LATE 2007. ANOTHER PALINDROME WAS INSERTED (LEFT IJ) ON THE NEXT DAY, THE CVC WAS IN PLACE 1 YR/8MO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME 19/36 KIT W/SLOT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145014 532501

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR