BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5447797 · Received February 19, 2016

    Report

    Report Number
    1417411-2016-00034
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 9, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. THREE PICTURES WERE RECEIVED FOR EVALUATION OF CATALOG NUMBER 003-40F (AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN). WHILE PERFORMING THE VISUAL INSPECTION TEST ON THE RECEIVED PICTURES, AN INCLINATION HAS BEEN APPRECIATED ON THE ASSEMBLY OF THE BOTTLE CONNECTED TO THE FLOWMETER WITH THE ADAPTOR; APPARENTLY THE NUT P/N 12228 IS SEPARATED FROM THE ADAPTOR P/N MP-0489. DEVICE HISTORY RECORD REVIEWED SHOWED THAT THERE WERE NO FUNCTIONAL ISSUES RELATED TO THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT 12228 (ADAPTOR, SNAP-ON FLOWMETER, (B)(4)) BATCH # 2-0615742, 3-0615741, 5-0515742, 5-0615741, 6-0615741 & 6-0615742 OF THE MATERIAL. NO SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. REGARDING THIS ISSUE CURRENT INVENTORY WAS VERIFIED, CONNECTING A COMPONENT FROM P/N 12228 (NUT) TO P/N MP-0489 (ADAPTOR) WHICH IS CONNECTED TO A BOTTLE TRYING TO SIMULATE THE APPLICATION AND NO ISSUES WERE FOUND. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON THIS RELATED ISSUE. IF THE 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 SCREW THREAD OF THE ADAPTOR DOES NOT HOLD AND WHEN THE PATIENT MOVES THE OXYGEN LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103146 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 441157

    Patients

    Seq Age Sex Outcome Treatment
    1