BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR

    MDR report key: 5257222 · Received December 1, 2015

    Report

    Report Number
    1417411-2015-00175
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    October 20, 2015
    Report Date
    November 17, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE SNAP-ON FLOWMETER ADAPTOR WAS NOT RETURNED WITH THE WATER BOTTLE. BASED ON THE LOT NUMBER OF THE RETURNED SAMPLE (142157) THE (B)(4) BATCH NUMBERS FOR COMPONENT MP-0321 (SNAP-ON FLOWMETER ADAPTOR) WERE OBTAINED. RECORDS REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT. BECAUSE THE ADAPTOR WAS NOT RETURNED, THE COMPLAINT COULD NOT BE CONFIRMED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED, DAMAGED THREADS ON THE ADAPTOR ARE A KNOWN ISSUE AND A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE. THE ROOT CAUSE FOR THE ISSUE WAS DETERMINED TO BE THE POSITIONING OF THE THREAD SOFTNESS OF THE NEW RESIN USED FOR THE SNAP ADAPTOR.

    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 WAS NOT RECEIVED AT OUR FACILITY. THE DEVICE HISTORY RECORD REVIEW SHOWED NO ISSUES RELATED TO FUNCTIONAL ISSUES ON MOLD COMPONENT INVOLVED IN THIS COMPLAINT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED, BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM A CORRECT INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. REGARDING OTHER CUSTOMER COMPLAINTS FOR THIS SAME ISSUE, A CAPA FILE (B)(4) WAS OPENED TO PERFORM A FURTHER INVESTIGATION INTO THIS ISSUE (THIS CAPA IS OWNED BY R & D). ACCORDING TO THE CAPA INVESTIGATION SO FAR THE ROOT CAUSE FOR THE ISSUE WAS THE POSITIONING OF THE THREAD LEAD AND THE SOFTNESS OF THE NEW RESIN USED FOR THE SNAP ADAPTOR. IF DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE OXYGEN IS LEAKING AT THE SCREW MECHANISM.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE OXYGEN IS LEAKING AT THE SCREW MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788572 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR RESPIRATORY GAS HUMIDIFIER BTT TELEFLEX MEDICAL 042157

    Patients

    Seq Age Sex Outcome Treatment
    1