BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXID 23/40 W / SH KIT W/VT

    MDR report key: 1011982 · Received March 11, 2008

    Report

    Report Number
    1317749-2008-00029
    Event Type
    Other
    Date Received
    March 11, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MSD
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 IN 2008 THAT A CUSTOMER HAD PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATED: "CATHETER HAD TO BE REPLACED DUE TO A CRACKED ADAPTER AT THE END OF THE CATHETER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXID 23/40 W / SH KIT W/VT DIALYSIS CATHETER MSD TYCO HEALTHCARE/KENDALL 8888145028 216108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK