BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER VERSO AIRWAY SZ2.0-4.0 ET TUBES

    MDR report key: 2832326 · Received November 14, 2012

    Report

    Report Number
    2050001-2012-00040
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    CAREFUSION RECEIVED USER FACILITY MEDWATCH (B)(4) FROM THE FDA ON (B)(4) 2012.  THE EVENT DESCRIPTION READS, "ETT AIRWAY ADAPTOR BECAME DISCONNECTED FROM VENT CAUSING PATIENT TO BE DISCONNECTED FROM VENTILATOR. IT WAS DISCOVERED THAT THE ETT SIZE ADAPTOR WAS NOT TIGHTLY CONNECTED TO THE "Y" ADAPTER. WHEN THE NURSE WENT TO RE-CONNECT IT WAS NOTED THAT A SMALL CLEAR RUBBER RING THAT HAD FALLEN OFF THE ADAPTER WAS NOTED TO BE IN THE ETT. THE ADAPTOR WAS REMOVED AND A NEW DEVICE ASSEMBLED AND ATTACHED. THERE WAS NO HARM TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER VERSO AIRWAY SZ2.0-4.0 ET TUBES CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI CAREFUSION CSC300

    Patients

    Seq Age Sex Outcome Treatment
    1