BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE ONE-WAY DISPOSABLE

    MDR report key: 2031936 · Received March 28, 2011

    Report

    Report Number
    8030673-2011-00003
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 28, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES RECEIVED WERE UNUSED SAMPLES. THE SAMPLES WERE EVALUATED ACCORDING TO OUR INSPECTION PROCEDURE AND IT WAS DETERMINED THAT THE THREE PIECES OF THIS PRODUCT CODE ARE CORRECTLY ASSEMBLED. IN ADDITION, THE VALVE AND GASKET WERE DIMENSIONALLY INSPECTED AND FOUND WITHIN SPECIFICATION. THEREFORE, WE ARE UNABLE TO CONFIRM THE ISSUE REPORTED WITH THE SAMPLES PROVIDED. THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. OUR MANUFACTURING PROCESS WAS REVIEWED AND NO ISSUES WERE FOUND RELATED WITH THE ISSUE REPORTED. THEREFORE, AT THIS TIME, A ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, AN INTERNAL INVESTIGATION HAS BEEN INITIATED CAPA (B)(4) TO INVESTIGATE FURTHER AND TO DETERMINE IF CORRECTIVE ACTIONS ARE APPLICABLE.

    Description of Event or Problem · 1

    GASKET VALVE DISLODGED FROM ASSEMBLY AND PATIENT INHALED. PATIENT REQUIRED A BRONCHOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALVE ONE-WAY DISPOSABLE VALVE ONE-WAY DISPOSABLE CBP CAREFUSION 001800 Y10S0086

    Patients

    Seq Age Sex Outcome Treatment
    1 Other