BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M

    MDR report key: 6285704 · Received January 30, 2017

    Report

    Report Number
    8040412-2017-00022
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    December 30, 2016
    Report Date
    January 5, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: CATALOG #: CORRECTED TO 2412-13. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THERE WERE HOLES IN THE TUBE. IT IS POSSIBLE THAT THIS DEFECT OCCURRED DUE TO MISHANDLING OF THE PRODUCT. THE FAILURE WAS REPORTED DURING USE ON A PATIENT. THE TUBE MUST BE SOFT AND FLEXIBLE IN ORDER TO MEET THE HFNC OXYGEN THERAPY AND USER REQUIREMENT; THUS IT IS PRONE TO TEARS AND PIN HOLES WHEN IT IS OVER PULLED AND STRETCHED. THE INSTRUCTIONS FOR USE (IFU) MENTIONS THAT THE TUBING SHOULD NOT BE STRETCHED TO REMOVE CONDENSATION, OR DAMAGE/MALFUNCTION MAY OCCUR. IN THE CURRENT MANUFACTURING PROCEDURE, 100% LEAK TESTING IS CONDUCTED DURING THE ASSEMBLY PROCESS AND 100% VISUAL INSPECTION IS DONE AT THE PACKING AREA. ANY DEFECTIVE PRODUCTS WOULD BE DETECTED PRIOR TO RELEASE FROM THE MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THERE WERE SMALL HOLES OR TEARS ON THE THIN, CLEAR PLASTIC MATERIAL OF THE CONNECTING TUBING. THE ALLEGED DEFECT WAS DETECTED DURING USE. REPORT STATES NO HARM OR INJURY TO PATIENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THERE WERE SMALL HOLES OR TEARS ON THE THIN, CLEAR PLASTIC MATERIAL OF THE CONNECTING TUBING. THE ALLEGED DEFECT WAS DETECTED DURING USE. REPORT STATES NO HARM OR INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70154 HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M CANNULA, NASAL OXYGEN CAT TELEFLEX MEDICAL 201626

    Patients

    Seq Age Sex Outcome Treatment
    1