BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 728 SW,760 ML W/028 ADAPTOR

    MDR report key: 5071352 · Received September 11, 2015

    Report

    Report Number
    1417411-2015-00141
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 28, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIX PICTURES FROM A SECTION OF THE PRODUCT CATALOG NUMBER 037-28 (AQUAPAK 728 SW , 760 ML W/028 ADAPTOR) WERE RECEIVED FOR ANALYSIS. THEY WERE VISUALLY INSPECTED AND NO ISSUES WERE FOUND; SAMPLE IS NEEDED IN ORDER TO PERFORM A PROPER INVESTIGATION OF THE ISSUE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE FAILURE MODE REPORTED WAS NOT CONFIRMED. THE PICTURES RECEIVED FOR EVALUATION DO NOT SHOW DAMAGE ON THE THREAD OF PART NUMBER MP-0321 "SNAP-ON FLOWMETER ADAPTOR". ALTHOUGH THE COMPLAINT MODE WAS NOT CONFIRMED FROM THE PICTURES RECEIVED, NUEVO LAREDO FACILITY HAS CONFIRMED THIS FAILURE MODE ON OTHER REPORTS RECEIVED. ADDITIONALLY, CAPA FILE (B)(4) WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT IT IS HARD TO ALIGN THE THREADS/CONNECTOR AND AS A RESULT THERE IS AN OXYGEN LEAK. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603609 HUDSON AQUAPAK 728 SW,760 ML W/028 ADAPTOR LARGE VOLUME NEBULIZER CCQ TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1