BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE TRI-FLO

    MDR report key: 2233332 · Received August 29, 2011

    Report

    Report Number
    2233332
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 29, 2011
    Manufacturer
    CAREFUSION 211, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    RN PULLED AN 8 FRENCH SUCTION CATHETER FROM THE PACKAGING TO PERFORM AN ENDOTRACHEAL SUCTIONING AND THE TIP OF THE CATHETER APPEARED TO BE MELTED TOGETHER. ANOTHER CATHETER CHECKED FROM THE SAME LOT NUMBER WAS OK. THE PRODUCT DID NOT REACH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE TRI-FLO TRIFLO SUCTION CATH AND GLOVE KIT 8FR BSY CAREFUSION 211, INC. * 0000319576

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY