BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6081454 · Received November 7, 2016

    Report

    Report Number
    1417411-2016-00131
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF PHOTOS INCLUDED IN THIS COMPLAINT SHOWS 2 DESIGNS FOR THE SNAP CAP THAT IS ASSEMBLED ON THE HUMIDIFIER ADAPTOR. BOTH DESIGNS HAVE BEEN VALIDATED AND APPROVED FOR USE. FUNCTIONAL ISSUE OF AIR LEAKING DURING USE CANNOT BE CONFIRMED FROM REVIEW OF THESE PHOTOS. THERE WAS NO DIMENSIONAL OR FUNCTIONAL INSPECTIONS FOR THE DEVICE INVOLVED, SINCE THE DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD REVIEW FOR THE 040 HUMIDIFIER ADAPTOR (LOTS 18C16 AND 19C16) PACKAGED WITH THE WATER LOT LISTED IN THIS COMPLAINT WAS REVIEWED: REVIEW OF MANUFACTURING EVENT LOG: SHOWS NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. ALL POST STERILITY AND PACKAGE INTEGRITY TESTS WERE ACCEPTABLE. IN CONCLUSION, NO ACTUAL DEVICE WAS AVAILABLE TO INVESTIGATE. PHOTOS WERE REVIEWED AND FUNCTIONAL ISSUE OF AIR LEAKING DURING USE CANNOT BE CONFIRMED FROM REVIEW OF THESE PHOTOS. COMPLAINT NOT CONFIRMED. ROOT CAUSE UNKNOWN. NO CORRECTIVE ACTIONS REQUIRED. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK ON ISSUES RELATED TO THIS COMPLAINT DESCRIPTION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES AN AIR LEAK DURING USE WITH THE DEVICE. THERE IS NO REPORT OF INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733391 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT HUMDIFIER NEB KIT OGG TELEFLEX MEDICAL 289167

    Patients

    Seq Age Sex Outcome Treatment
    1