BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALINDROME EMERALD 28/45KIT VT

    MDR report key: 1053576 · Received May 28, 2008

    Report

    Report Number
    1317749-2008-00092
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 28, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: MAY 28, 2008. 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 IN 2008, THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. CUSTOMER REPORTS THAT A PT HAD A PALINDROME CATHETER EXCHANGED DUE TO CRACKING OF THE VENOUS HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME EMERALD 28/45KIT VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145045 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK