BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

    MDR report key: 7615399 · Received June 19, 2018

    Report

    Report Number
    3004365956-2018-00201
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 30, 2018
    Report Date
    May 31, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    PMA / PMN Number
    K153010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SAMPLE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING, IN A (B)(6) BAG WITH A DISINFECTION TAG. VISUAL INSPECTION ON THE INTERNAL THREAD OF COMPONENT ADAPTOR (TFX-001743) REVEALED SIGNS OF STRESS AT THE BEGINNING OF THE THREAD. FUNCTIONAL INSPECTION WAS CONDUCTED. THE UNIT WAS CONNECTED TO THE OXYGEN STATION GETTING AS A RESULT AN UNSTABLE CONNECTION. THEN BY APPLYING A SMALL AMOUNT OF PRESSURE TOWARDS THE BACK OF THE NEBULIZER THE LOWER PART OF THE NEBULIZER GOT DISCONNECTED FROM THE ADAPTOR (TXF-001743). AN UNUSED ADAPTOR (TXF-001743) WAS PLACED IN THE NEBULIZER IN ORDER TO CONNECT THE UNIT BACK AGAIN TO THE OXYGEN STATION. NO PROBLEM WAS FOUND. AN ATTEMPT TO DUPLICATE THE FAILURE MODE REPORTED WAS DONE WITH AN UNUSED ADAPTOR AND THE ACTUAL COMPLAINT UNIT. (CONT.) OTHER REMARKS: FAILURE MODE WAS REPLICATED BY OVERTIGHTENING THE ADAPTOR TO THE OXYGEN STATION. A VISUAL INSPECTION OF THIS ADAPTOR SHOWED THE SAME STRESS MARKS CONDITION AT THE TABS. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT IS CONFIRMED. HOWEVER, BASED ON THE ANALYSIS OF THE SAMPLE RECEIVED, THERE IS NOT ENOUGH EVIDENCE TO ASSURE THAT THIS FAILURE MODE ORIGINATED DURING THE MANUFACTURING AND/OR MOLDING PROCESS. THE STRESS MARKS OBSERVED ON THE INTERNAL TABS OF ADAPTOR (TFX-001743) WERE CAUSED MORE LIKELY BY THE END USER WHILE CONNECTING THE ADAPTOR INTO THE FLOWMETER CAUSING AN UNSTABLE CONNECTION THEREFORE CAUSING THE UNIT TO FALL. TELEFLEX WILL CONTINUE TO MONITOR CUSTOMER FEEDBACK FOR COMPLAINTS OF THIS NATURE. PERSONNEL OF THE ASSEMBLY LINE WERE NOTIFIED FOR AWARENESS.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE CONNECTION BETWEEN THE ADAPTOR AND THE AQUATHERM HEATER WAS LOOSE, SO THE ADAPTOR SOON DETACHED FROM THE HEATER. THEREFORE, A NEW UNIT WAS USED INSTEAD."

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE OR A PICTURE OF THE ALLEGED DEFECT WAS NOT PROVIDED AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION TO CONFIRM THE ALLEGED DEFECT, AND DETERMINE THE ROOT CAUSE. IF THE SAMPLE BECOMES AVAILABLE THIS REPORT WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE CONNECTION BETWEEN THE ADAPTOR AND THE AQUATHERM HEATER WAS LOOSE, SO THE ADAPTOR SOON DETACHED FROM THE HEATER. THEREFORE, A NEW UNIT WAS USED INSTEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454896 HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE NEBULIZER (DIRECT PATIENT INTE CAF TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 AQUATHERM HEATER| AQUATHERM HEATER