BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISTY OX MULTI-FIT

    MDR report key: 6082264 · Received November 7, 2016

    Report

    Report Number
    8030673-2016-00257
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    September 14, 2016
    Report Date
    January 16, 2017
    Manufacturer
    CAREFUSION/BD
    Product Code
    CCQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION HAS CONFIRMED THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. ATTEMPTS HAVE BEEN MADE BY CUSTOMER ADVOCACY TO GAIN ADDITIONAL INFORMATION FROM THE CUSTOMER AND END USER REGARDING SITUATION REPORTED WITH THE DEVICE. CUSTOMER ADVOCACY IS STILL WAITING FOR ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUE. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW UP SUBMISSION: NO PHYSICAL SAMPLE WAS PROVIDED FOR EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED AND THE BLACK RING WITH PART NUMBER (B)(4) WAS MISSING FROM THE WHITE COLLAR (WING NUT P/N (B)(4)). THE ROOT CAUSE OF THE REPORTED ISSUE IS RELATED TO THE ASSEMBLY PERSONNEL AT NOT ASSEMBLING THE COMPONENTS CORRECTLY. TO CORRECT THIS ISSUE, MANUFACTURING PERSONNEL HAVE BEEN RETRAINED ON THE ASSEMBLY PROCEDURE TO AVOID THESE TYPES OF ISSUES. A 2-YEAR RETROSPECTIVE COMPLAINT REVIEW WAS PERFORMED AND NO ADVERSE TREND WAS IDENTIFIED RELATING TO THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE RESPIRATORY THERAPIST (RT) WENT TO SEE THE PATIENT ON 96% HIGH FLOW NASAL CANNULA, AND THE PATIENT WAS DESATURATING ON RT'S ARRIVAL INTO THE ROOM. RN REPORTED THAT THE PRODUCT FELL OFF WALL FROM WHITE COLLAR. RT WENT TO ASSESS AND THERE WAS NO BLACK O RING, WHITE COLLAR STILL ATTACHED TO FLOW METER AND YELLOW COLLAR FALLING OFF. IT WAS CONFIRMED THAT THERE WAS PATIENT INVOLVEMENT WITH NO PERMANENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732174 MISTY OX MULTI-FIT NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) CCQ CAREFUSION/BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention