BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALINDROME 28/45 KIT WITH SLOT

    MDR report key: 1051783 · Received May 20, 2008

    Report

    Report Number
    1317749-2008-00080
    Event Type
    Other
    Date Received
    May 20, 2008
    Date of Event
    December 30, 2007
    Report Date
    May 19, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 5/19/08 THAT A PT HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTED THAT THE PT GOT THE CATHETER IN 2007. ABOUT 7 DAYS LATER, THE CUSTOMER NOTICED THAT IT WAS A CRACK IN ONE OF THE ULTEM ADAPTERS. IN APRIL THEY DECIDED TO TAKE AWAY THE PALINDROME. A NEW CATHETER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME 28/45 KIT WITH SLOT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145016 536001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK