BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/SLOT

    MDR report key: 982512 · Received January 22, 2008

    Report

    Report Number
    1317749-2008-00010
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    December 26, 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 UNDERWAY. 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 IN LATE 2007. THE CUSTOMER STATES THAT THERE WAS NO PULLING ON THE CATHETER, THERE WAS NO INFECTION AND NO INFLAMMATION HAD OCCURRED. THIS COMPLAINT IS FROM A FEMALE, WHO IS BUXOM, 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 SAME DAY. THE CVC WAS IN PLACE 1 YR/3MO."

    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 613501

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR