BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK AIR ENTRAIN ADULT 50/CS

    MDR report key: 2969261 · Received February 20, 2013

    Report

    Report Number
    8030673-2013-00015
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BYF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): AN UNUSED SAMPLE WAS RECEIVED AT THE MANUFACTURING PLANT FOR EVALUATION. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: UPON SAMPLE RETURN, A 50% VENTURI ADAPTER WAS FOUND TO BE OCCLUDED. THE ADAPTER IS A SUPPLIED COMPONENT TO CAREFUSION. THE SUPPLIER THAT MANUFACTURES THIS PART WAS NOTIFIED OF THE DEFECT. A PROJECT INITIATION WAS REQUESTED TO THE SUPPLIER BY CAREFUSION TO DETERMINE THE ROOT CAUSE FOR THE ADAPTER BEING OCCLUDED. CAREFUSION PLANS TO IMPLEMENT ADDITIONAL QUALITY INSPECTIONS AT THE ASSEMBLY LINE PROCESS IN ORDER TO IMMEDIATELY DETECT THIS TYPE OF FAILURE IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    MANUFACTURING PLANT CONFIRMED THAT UPON SAMPLE RETURN, AN OCCLUDED 50% VENTI ADAPTOR WAS DISCOVERED. NO PATIENT INVOLVEMENT, DISCOVERED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74046 MASK AIR ENTRAIN ADULT 50/CS MASK, OXYGEN, LOW CONCENTRATION, VENTURI BYF CAREFUSION 001240-A 000493387

    Patients

    Seq Age Sex Outcome Treatment
    1