BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,JAP

    MDR report key: 8264954 · Received January 21, 2019

    Report

    Report Number
    1417411-2019-00011
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    December 28, 2018
    Report Date
    January 8, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ONE SAMPLE WAS RECEIVED FOR EVALUATION OF PRODUCT CODE 006-40J (AQUAPAK 640 SW,650 ML W/040 ADAPTOR, JAPANESE); MP-0489 (PIN ADAPTOR BODY 040) AND TFX-001743 (ADAPTOR, SNAP-ON FLOWMETER RESIN RE-0042) WHICH ARE PART OF FINISHED GOOD 006-40J. A VISUAL INSPECTION WAS PERFORMED, AND DAMAGES WERE OBSERVED IN THE FOLLOWING MOLDED COMPONENTS: TFX-001743 (ADAPTOR, SNAP-ON FLOWMETER RESIN RE-0042): A DAMAGED IS OBSERVE IN ALL THE INSIDE RIBS OF THE COMPONENT, THIS CAN BE A RESULT OF AN INCORRECT USE OF THE DEVICE; ALSO, A STRONG HIT CAN BE OBSERVED ON ONE EDGE OF THE COMPONENT. MP-0489 (PIN ADAPTOR BODY 040): A DAMAGED IS OBSERVE IN ALL RETENTION TABS OF THE COMPONENT, TWO RETENTION TABS ARE COMPLETELY BROKEN, AND ONE TAB IS BENT. BASED ON THE DAMAGE FOUND ON THE RECEIVED SAMPLE IT WAS CONCLUDED THAT THE DEVICE WAS USED INCORRECTLY, SINCE IT SEEMS THAT COMPONENT PART NUMBER TFX-001743 WAS OVER TIGHTENED ON THE FLOWMETER UNTIL THIS FAILURE OCCURRED. HOWEVER, ALL MATERIAL FROM CURRENT INVENTORY AT THE MANUFACTURING FACILITY WAS VERIFIED AND NO ISSUES WERE FOUND THAT CAN LEAD TO THIS CUSTOMER COMPLAINT, THEREFORE THIS CUSTOMER COMPLAINT CANNOT BE CONFIRMED AS A MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE CONNECTING PART ASSEMBLY BETWEEN THE HUMIDIFIER ADAPTOR OF AQUAPAK BOTTLE AND THE FLOWMETER CAME OFF WHEN SCREWING." THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION AT THE TIME OF THIS REPORT. BASED ON THE LOT PROVIDED, FOR WHICH THE DEVICE HISTORY RECORD RESIDES AT (B)(6) FACILITY, THE NUEVO LAREDO LOT NUMBERS WERE OBTAINED. RECORDS REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENTS INVOLVED IN THIS COMPLAINT. TO PERFORM A PROPER AND THOROUGH INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED. ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS REPORT WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE CONNECTING PART ASSEMBLY BETWEEN THE HUMIDIFIER ADAPTOR OF AQUAPAK BOTTLE AND THE FLOWMETER CAME OFF WHEN SCREWING." THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58140 HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,JAP HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 18E016

    Patients

    Seq Age Sex Outcome Treatment
    1 FLOWMETER.| FLOWMETER.