BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT TUBE

    MDR report key: 1011656 · Received March 10, 2008

    Report

    Report Number
    1527460-2008-00373
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ROSS STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    COMPLAINANT REPORTS A PORT LEAK. TUBE IS STILL IN PLACE. CONTINUOUSLY DRIPS WHEN Y-PORT IN DOWN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT TUBE 78 KNT TUBES, GASTROINTESTINAL, ACCESSORIES KNT ROSS PRODUCTS DIVISION 51362 58536GZ

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR