BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8856970 · Received August 2, 2019

    Report

    Report Number
    1417411-2019-00035
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    November 12, 2018
    Report Date
    July 8, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONE EMPTY 340 ML WATER BOTTLE LOT 220177 WAS RECEIVED EMPTY FOR EVALUATION WITH THE TRIGGER REMOVED AND TOP OF ADAPTOR PORT INTACT. IT CAME WITHOUT THE 040 HUMIDIFIER ADAPTOR. UPON VISUAL INSPECTION, THERE APPEARS TO BE A CHANNEL FROM THE BOTTOM OF THE ADAPTOR PORT TO THE TOP OF THE BOTTLE. THE BOTTLE WAS FILLED ABOUT 3/4 FULL WITH WATER AND AN ADAPTOR (LOT 17F18) WAS ATTACHED. THE WATER BOTTLE/ADAPTOR ASSEMBLY WAS ATTACHED TO A FLOWMETER. NO BUBBLES WERE OBSERVED AT 0.5 LITERS PER MINUTE OR AT 1 LITER PER MINUTE. UPON INCREASING THE AIR FLOW BUBBLES APPEARED IN THE BOTTLE. A REVIEW OF THE MANUFACTURING EVENT LOG OF THE LOT NUMBER REPORTED SHOWS NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION AND ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT IS CONFIRMED. CORRECTIVE ACTION HAS BEEN TAKEN. THE RETURNED SAMPLE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT STATES: "PRESENCE OF A BUBBLE IN THE PLASTIC PART THAT CONNECTS THE PLUG IN OF THE OXYGEN TO THE AQUAPACK BOTTLE. SO IT OCCLUDES THE FLOW OF OXYGEN." THE CONDITION OF THE PATIENT IS REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT STATES: "PRESENCE OF A BUBBLE IN THE PLASTIC PART THAT CONNECTS THE PLUG IN OF THE OXYGEN TO THE AQUAPACK BOTTLE. SO IT OCCLUDES THE FLOW OF OXYGEN." THE CONDITION OF THE PATIENT IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649948 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 220177

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.