BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40KT VT

    MDR report key: 1062814 · Received June 18, 2008

    Report

    Report Number
    1317749-2008-00105
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: JUNE 18, 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. THE CUSTOMER STATED THAT THE BLUE ADAPTER WAS CRACKED ON THE HUB OF THE DIALYSIS CATHETER. THE CAUSE WAS UNKNOWN. THE CATHETER NEEDED TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME SAPPHIRE 23/40KT VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145048 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK