BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV

    MDR report key: 6112333 · Received November 18, 2016

    Report

    Report Number
    3004365956-2016-00426
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 7, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. A CORRECTIVE ACTION CANNOT BE APPLIED SINCE IT IS NOT POSSIBLE TO IDENTIFY THE DEFECT REPORTED AND TO INVESTIGATE ITS ROOT CAUSE, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. HOWEVER MATERIAL FROM THE PRODUCTION LINE WAS FUNCTIONALLY TESTED AND NO ISSUES WERE DETECTED THAT CAN LEAD TO THIS CUSTOMER COMPLAINT. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DEVICE DOES NOT NEBULIZE THE MEDICATION.THE ALLEGED ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765416 HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV NEBULIZER, NON-VENTILATING CCQ TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 FLOW METER