BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5431350 · Received February 11, 2016

    Report

    Report Number
    1417411-2016-00033
    Event Type
    Malfunction
    Date Received
    February 11, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 5, 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

    QN#(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,FR.). 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 12228 IS SEPARATED FROM THE ADAPTOR MP-0489. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THIS CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THIS ISSUE WAS ORIGINATED DURING THE MANUFACTURING PROCESS. THE DEVICE SAMPLE IMPLICATED IN THIS COMPLIANT IS NEEDED TO PERFORM A PROPER INVESTIGATION. IF DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED. (B)(4) FACILITY WILL CONTINUE TO TRACK AND TREND THIS FAILURE MODE. REGARDING THIS ISSUE CURRENT INVENTORY WAS VERIFIED, CONNECTING A COMPONENT FROM PART NUMBER 12228 (NUT) TO MP-0489 (ADAPTOR) WHICH IS CONNECTED TO A BOTTLE TRYING TO SIMULATE THE APPLICATION AND NO ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: DATE OF EVENT CORRECTED TO (B)(6) 2016. LOT # WAS IDENTIFIED AS 544157. BASED ON THE LOT 544157 PROVIDED FOR WHICH THE DHR RESIDES AT (B)(4) FACILITY, THE (B)(4) LOT NUMBERS FOR COMPONENT 12228 (NUT) WERE OBTAINED. RECORDS REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT (B)(4) (ADAPTOR, SNAP-ON FLOWMETER, FRENCH) BATCH # 2-2915742, 3-2815741 , 3-2815742, 3-2915742 & 4-2815741 DURING THE MANUFACTURE OF THE MATERIAL. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    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.

    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
    88414 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 544157

    Patients

    Seq Age Sex Outcome Treatment
    1