BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-ACCESS CATHETER

    MDR report key: 5839438 · Received August 2, 2016

    Report

    Report Number
    5839438
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 19, 2016
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MULTI-ACCESS (MAC) CATHETER WAS USED FOR SURFACTANT ADMINISTRATION; IT IS INTENDED FOR MULTI-USE OVER 3 SURFACTANT DOSES. ON THE SECOND ADMINISTRATION, A SMALL LEAK WAS NOTED AT THE HUB. ON THE THIRD ADMINISTRATION A SIGNIFICANT PORTION OF THE DOSE WAS LOST THROUGH THE CRACK IN THE HUB. STAFF WAS ABLE TO REPLACE FROM THE SECOND VIAL THAT HAD ALREADY BEEN ACCESSED. CATHETER PACKAGING AND INFORMATION HAD BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492403 MULTI-ACCESS CATHETER CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY HALYARD HEALTH, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR