BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST NEBULIZER W/ELONG

    MDR report key: 4834356 · Received June 9, 2015

    Report

    Report Number
    3004365956-2015-00157
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    January 9, 2015
    Report Date
    May 25, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT OR A PICTURE OF THE DEFECT WAS NOT PROVIDED. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. HOWEVER, CURRENT PRODUCTION SAMPLES OF CATALOG 1886 MICRO MIST NEBULIZER W/ELONG BATCH NUMBER 74E1502761 WERE TESTED ACCORDING TO (B)(4) USED TO RELEASE THE PRODUCTION PARTS AND NO ISSUES WERE FOUND THAT CAN LEAD TO THE CONDITION REPORTED BY THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE THE SAMPLE IS NOT AVAILABLE TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF SAMPLE AND NO PICTURE. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS ALSO PERFORMED AND NO ISSUES WERE FOUND. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE NEBULIZER IS NOT GIVING AN EFFICIENT NEBULIZATION RATE. THE ALLEGED ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE NEBULIZER IS NOT GIVING AN EFFICIENT NEBULIZATION RATE. THE ALLEGED ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370330 HUDSON MICRO MIST NEBULIZER W/ELONG SMALL VOLUME NEBULIZER CCQ TELEFLEX MEDICAL 74F1400150

    Patients

    Seq Age Sex Outcome Treatment
    1