BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/7 FT

    MDR report key: 6587708 · Received May 24, 2017

    Report

    Report Number
    3004365956-2017-00196
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    May 8, 2017
    Report Date
    May 8, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE MANUFACTURER REPORTS THAT NO ISSUES COULD BE FOUND WITH THE SAMPLE DURING FUNCTIONAL TESTING. THE DEVICE FUNCTIONED AS INTENDED. EVALUATION CODES HAVE BEEN UPDATED TO REFLECT THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW SHOWS THAT THE DEVICE WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. THE DEVICE WAS RECEIVED FOR INVESTIGATION. CUSTOMER PROVIDED VIDEO OF THE COMPLAINT REVIEWED. DURING THE VISUAL INSPECTION, WHITE RESIDUE WAS FOUND INSIDE OF THE JAR, ON THE CAP AND JET. NO OTHER DEFECTS OR ANOMALIES WERE FOUND. A FUNCTIONAL INSPECTION WAS PERFORMED USING THE RETURNED DEVICE AND TUBING. A TOTAL OF 5CC OF WATER WAS ADDED TO THE RETURNED NEBULIZER UNIT. THEN THE TUBING WAS CONNECTED TO AN AIR FLOWMETER AND THE PRESSURE WAS INCREASED TO 8 LPM. MIST WAS PRODUCED FROM THE CHAMBER OF THE NEBULIZER, HOWEVER AFTER 4 MINUTES THE TUBING POPPED OFF. IN CONCLUSION, THE REPORTED COMPLAINT THAT THE DEVICE GIVES LITTLE OR NO AEROSOL DURING USE COULD NOT BE CONFIRMED THROUGH THE FUNCTIONAL INSPECTION OF THE RETURNED SAMPLE. HOWEVER, THE TUBING POPPED OFF OF THE FLOWMETER AFTER 4 MINUTES OF FUNCTIONAL TESTING. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE DEVICE IS PRODUCING "LITTLE OR NO AEROSOL". ALLEGED MALFUNCTION REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE DEVICE IS PRODUCING "LITTLE OR NO AEROSOL". ALLEGED MALFUNCTION REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369811 HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/7 FT NEBULIZER CAF TELEFLEX MEDICAL 74A1700627

    Patients

    Seq Age Sex Outcome Treatment
    1