BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC

    MDR report key: 3904682 · Received May 27, 2014

    Report

    Report Number
    3004365956-2014-00200
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 12, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IN WHICH CONDITIONS THIS MATERIAL WAS MANUFACTURED. 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, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. HOWEVER, ALL PERSONNEL FROM THE PRODUCTION LINE WILL BE NOTIFIED TO MAKE THEM AWARE OF THIS ISSUE. IF THE DEFECTIVE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT WHILE PREPARING THE NEBULIZER FOR USE, IT WAS DISCOVERED THAT THE MOUTHPIECE OF THE DEVICE WAS MISSING FROM THE PACKAGE. THE PATIENT'S SAFETY AND WELL BEING WAS NOT JEOPARDIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311778 HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC SMALL VOLUME NEBULIZER CAF TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1