BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR

    MDR report key: 6677556 · Received June 29, 2017

    Report

    Report Number
    1417411-2017-00038
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 22, 2017
    Report Date
    June 26, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    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 WAS NOT RECEIVED YET AT OUR FACILITY AND NO PICTURES HAS BEEN RECEIVED FOR EVALUATION OF THE ALLEGED DEFECT REPORTED. BASED ON THE LOT 573167 PROVIDED, THE NUEVO LAREDO LOT NUMBERS FOR COMPONENT TFX-001743 WERE OBTAINED. RECORDS REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT TFX-001743 (ADAPTOR, SNAP-ON FLOWMETER RESIN RE-0042) BATCH # 1-3016741, 3-2916742, 4-2916741, 4-2916742, 5-2916741 & 6-2916741 DURING THE MANUFACTURE OF THE MATERIAL. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS TIME SINCE THE DEVICE SAMPLE OR PICTURES OF THE ALLEGED DEFECT ARE NOT AVAILABLE FOR EVALUATION. IN ORDER TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE SOURCE OF THE ALLEGED DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE PHYSICAL DEVICE SAMPLE INVOLVED IN THIS COMPLAINT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. IF DEVICE BECOMES AVAILABLE AT A LATER DATE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE SNAP CAP IS PLACED TOO FAR DOWN THE ADAPTOR BODY. BASED ON THE VISUAL EXAM, THE COMPLAINT WAS CONFIRMED. A NON-CONFORMANCE WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "CONNECTION ADAPTER FAULTY - CANNOT CONNECT TO THE OXYGEN POINT." ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO PATIENT USE. NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "CONNECTION ADAPTER FAULTY - CANNOT CONNECT TO THE OXYGEN POINT." ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO PATIENT USE. NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458726 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 573167

    Patients

    Seq Age Sex Outcome Treatment
    1 OXYGEN POINT