BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,

    MDR report key: 8691013 · Received June 12, 2019

    Report

    Report Number
    3004365956-2019-00140
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 21, 2019
    Report Date
    May 21, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    PMA / PMN Number
    K153010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ONE (1) UNIT OF FG 031-28J "NEBULIZER ADAPTOR 028,STERILE,SHELFPAK," WAS RECEIVED FOR ANALYSIS. SIGNS OF USE ARE OBSERVED SINCE A DISINFECTION TAG IS PRESENT AND THE SAMPLE WAS NOT RECEIVED ON ITS ORIGINAL PACKAGE. NO OTHER ISSUES WERE FOUND. SAMPLE WAS TESTED ON OXYGEN ENTRAINMENT TEST (TP-0041 REV.26) AND DURING THE SETUP IT WAS OBSERVED THAT THE ASSEMBLY OF THE NUT ADAPTOR COMPONENT P/N TFX-001743 AND THE UPPER BODY COMPONENT P/N MP-0527 WAS UNSTABLE. EVEN WITH THAT CONDITION, THE SAMPLE WAS ABLE TO BE TESTED ON OXYGEN ENTRAINMENT TESTING (TP-0041) BUT THE TESTING FAILED DUE SUCH CONDITION. AFTER THE TESTING FINISHED, THE COMPONENT P/N TFX-001743 WAS CAREFULLY DISASSEMBLED FROM THE COMPONENT UPPER BODY MP-0527 AND IT WAS VISUALLY INSPECTED. DURING THE VISUAL INSPECTION IT WAS FOUND WEAR ON ITS INTERNAL TABS. A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE ADDITIONAL INSPECTION ON THE COMPONENT TFX-001743 OF THE SAMPLE RECEIVED, THE COMPLAINT IS CONFIRMED. ALTHOUGH THE CONDITION OBSERVED ON THE SAMPLE PROVIDED, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THAT THIS ISSUE WAS ORIGINATED DURING THE MANUFACTURING ASSEMBLY OR MOLDING PROCESS. THE WEAR ON THE INTERNAL TABS OF COMPONENT TFX-001743 MOST LIKELY BE CAUSED BY THE END USER DURING THE CONNECTION OF THE ADAPTOR INTO THE FLOWMETER THAT CAUSES AN UNSTABLE CONNECTION ISSUE. BASED ON PREVIOUS STATEMENTS IT IS NOT POSSIBLE TO ESTABLISH A CORRECTIVE ACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ADAPTOR CAUSING AN UNSTABLE CONNECTION WITH AQUAPAK BOTTLE AND FLOWMETER. THE ADAPTOR WAS REPLACED WITH A NEW ONE. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ADAPTOR CAUSING AN UNSTABLE CONNECTION WITH (B)(6) BOTTLE AND FLOWMETER. THE ADAPTOR WAS REPLACED WITH A NEW ONE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485867 NEBULIZER ADAPTOR 028,STERILE,SHELFPAK, NEBULIZER (DIRECT PATIENT INTE CAF TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1