BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSO AIRWAY ACCESS ADAPTER

    MDR report key: 2554635 · Received May 6, 2010

    Report

    Report Number
    2050001-2010-00003
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    March 10, 2010
    Report Date
    May 5, 2010
    Manufacturer
    CAREFUSION
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RECEIVED FOR EVAL; THEREFORE, WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE ISSUE REPORTED. THIS IS THE FIRST FORMAL REPORT OF BREAKAGE INVOLVING BREAKAGE WITH SPLINTERING OF THE PLASTIC IN SEPARATE PIECES. WE WILL CONTINUE TO MONITOR OUR PRODUCTS PERFORMANCE FOR ADDITIONAL REPORTS OF THIS TYPE OF BREAKAGE. WE DO NOT ANTICIPATE PHYSICAL BREAKAGE OF THE PLASTIC IN THE MANNER DESCRIBED IN THE REPORT WITHOUT CONSIDERABLE FORCE BEING APPLIED TO THE COMPONENT.

    Description of Event or Problem · 1

    PT IN THE ICU AND WHILE THE PT WAS BEING TURNED, THE NURSE HEARD AIR LEAK. THE VERSO ADAPTER HAD SNAPPED IN TWO AND PART OF IT REMAINED IN THE PT. THE PT BECAME DISCONNECTED FROM THE VENTILATOR. ONE NURSE HELD ONTO THE ADAPTER AND KEEPING IN-LINE SUCTION TOGETHER WHILE THE OTHER WAS USING THE AMBU BAG TO VENTILATE THE PT. PIECE WAS REMOVED FROM PT'S THROAT WITH FORCEPS WITHOUT INJURY. IN-LINE SUCTION WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSO AIRWAY ACCESS ADAPTER VERSO AIRWAY ACCESS ADAPTER BZA CAREFUSION CSC100 09060014

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other