BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-S

    MDR report key: 5823107 · Received July 26, 2016

    Report

    Report Number
    8040412-2016-00164
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 22, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCOMPLETE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, TEN PIECES OF CATALOG NUMBER 2412-13 WERE SELECTED FROM CURRENT PRODUCTION AT THE MANUFACTURING FACILITY TO TEST THE REPORTED DEFECT. THE SAMPLES WERE ALL VISUALLY INSPECTED AND NO ISSUES WERE OBSERVED. IN ADDITION, LEAK TESTING WAS ALSO PERFORMED ON ALL TEN SAMPLES, AND NO LEAKS WERE DETECTED. BECAUSE NO SAMPLE WAS RETURNED, THE COMPLAINT COULD NOT BE CONFIRMED. IN THE CURRENT MANUFACTURING PROCEDURE, 100% LEAK TESTING IS CONDUCTED AT THE ASSEMBLY AREA; THEREFORE, ANY DEFECTS WOULD BE DETECTED PRIOR TO RELEASE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THERE ARE SMALL HOLES NEAR THE NARE CONNECTION THAT LEAKS OXYGEN. THE DEVICE WAS REMOVED AND A NEW DEVICE OBTAINED. NO PATIENT INJURY/HARM REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THERE ARE SMALL HOLES NEAR THE NARE CONNECTION THAT LEAKS OXYGEN. THE DEVICE WAS REMOVED AND A NEW DEVICE OBTAINED. NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476070 HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-S NASAL OXYGEN CANNULA CAT TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1