BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE, TRI-FLO

    MDR report key: 1074464 · Received June 25, 2008

    Report

    Report Number
    1074464
    Event Type
    Malfunction
    Date Received
    June 25, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 25, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    OFR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    NURSE AND RESPIRATORY THERAPIST WERE ATTEMPTING TO SUCTION THE ENDOTRACHEAL TUBE OF AN INFANT ON A VENTILATOR WITH THE SUCTION CATHETER. WHEN THEY PASSED THE CATHETER INTO THE ET TUBE AND COVERED THE PORT TO APPLY SUCTION IT WAS FOUND THAT THE CATHETER WAS NOT PATENT. THERE WAS A BLOCKAGE WITHIN THE CATHETER THAT MADE IT DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE, TRI-FLO KIT, SUCTION OFR CARDINAL HEALTH * Y08D1096

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO