BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALIND 23/40 SLOT KIT W/VT

    MDR report key: 1033464 · Received April 23, 2008

    Report

    Report Number
    1317749-2008-00066
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 25, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 STATED: A DIALYSIS CATHETER ADAPTER CRACKED AND NEEDED EXCHANGED, CATHETER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALIND 23/40 SLOT KIT W/VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK