BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4999633 · Received August 13, 2015

    Report

    Report Number
    3004365956-2015-00211
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 OR A PICTURE OF THE DEFECT WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE LOT NUMBER WAS NOT PROVIDED AND SAMPLE IS NOT AVAILABLE TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS. HOWEVER, A PUSH TEST WAS PERFORMED ON CURRENT PRODUCTION SAMPLES OF P/N: 12152 AND AN AVERAGE FORCE OF 70.39 POUNDS ARE NECESSARY TO BREAK THE STEM OF THE JAR.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT UPON ATTEMPTING TO REMOVE THE OXYGEN GAS LINE AT THE BOTTOM OF THE NEBULIZER THE PLASTIC MALE PORT BREAKS OFF. THE ALLEGED ISSUE WAS ENCOUNTERED AFTER THE TREATMENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537104 HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV SMALL VOLUME NEBULIZER CCQ TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1