BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALIND 19/36 SLOT SPRT W/VT

    MDR report key: 1010135 · Received March 10, 2008

    Report

    Report Number
    1317749-2008-00044
    Event Type
    Other
    Date Received
    March 10, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 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 UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON FEB 15, 2008 THAT A CUSTOMER HAD PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER NOTICED PT HAD CRACKED ADAPTERS, AND HAD TO HAVE CATHETER REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALIND 19/36 SLOT SPRT W/VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888119364 728948

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK