BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, INT

    MDR report key: 4398296 · Received January 6, 2015

    Report

    Report Number
    1417411-2015-00008
    Event Type
    Malfunction
    Date Received
    January 6, 2015
    Date of Event
    December 9, 2014
    Report Date
    December 12, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED LOT NUMBER - 4161167. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RECEIVED YET AT OUR FACILITY. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS MOMENT SINCE THE DEVICE SAMPLE OR A PICTURE IS NOT AVAILABLE FOR EVALUATION. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE, BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS IT BEING MANUFACTURED AT THE TIME. 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 IT IS NEARLY IMPOSSIBLE TO SCREW THE ADAPTOR ON THE FLOW METER. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9772 HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, INT HUMIDIFIER BTT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1