BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALINDROME RUBY 23 / 40 KIT VT

    MDR report key: 1023758 · Received March 25, 2008

    Report

    Report Number
    1317749-2008-00052
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 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

    ADDITIONAL INFO WAS RECEIVED THAT CATHETER WAS REPLACED. 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 2008 THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. CUSTOMER REPORTED THAT THEY HAD A PROBLEM WITH A BACK END OF A DIALYSIS CATHETER AND IT NEEDED A REPAIR. THE VENOUS TRAC ADAPTER CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME RUBY 23 / 40 KIT VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145063 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK