BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25" OXYGEN CANNULA

    MDR report key: 8274139 · Received January 23, 2019

    Report

    Report Number
    MW5083347
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    August 29, 2018
    Report Date
    January 21, 2019
    Manufacturer
    WESTMED, INC.
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WESTMED INC CREATED A 25 FOOT COMFORT SOFT PLUS CANNULA PRODUCT# 0551-TN, FOR THE (B)(6), IN (B)(6). THIS CANNULA CAN BE USED FOR FLOWS FROM 1 LPM UP TO 15 LPM. ON WEDNESDAY, (B)(6) 2018, I WAS CONTACTED BY AN RT AT (B)(6) WHO DESCRIBED NO OXYGEN FLOW IN RANDOM CANNULAS THROUGH OUT THE HOSP. I SENT A PRODUCT COMPLAINT REPORT TO REGULATORY WITHIN WESTMED INC. I THEN MET WITH THE RESPIRATORY SAFETY BOARD AT (B)(6) HOSP; 4 OF THE 8 (B)(6) LOCATIONS REPORTED FULL OCCLUSIONS OF THE CANNULAS IN A RANDOM PATTERN. WE WERE ASKED TO DO A HOSP PRODUCT "AUDIT" TO GET ANY OCCLUDED CANNULAS OUT OF THE HOSP. WE DID DO AN INSPECTION AND FOUND 12 OCCLUDED/SEMI-OCCLUDED CANNULAS. THIS WAS REPORTED BACK TO WESTMED, BUT NO OTHER ACTIONS WERE TAKEN. I HAVE SENT A REQUEST TO WESTMED REGULATORY, ASKING TO EXPLAIN WHAT THE ISSUE WAS AND HOW THEY REMEDIED THE ISSUE, BUT I HAVE STILL NOT GOT AN ANSWER. WESTMED DID NOT DO A RECALL OR A DEAR DOCTOR LETTER WARNING OF POSSIBLE OCCLUSIONS, NOR HAVE THEY PROVIDED A RESOLUTION TO ME, THE SALES REP, OR (B)(6). I FEEL I AM PUT IN THE SITUATION WHERE I NEED TO KEEP PTS PROTECTED AND SAFE. I DO NOT WANT TO BE RESPONSIBLE FOR A HYPOXIC EVENT IN A HOSP PT. I WILL BE GLAD TO ANSWER ANY FURTHER QUESTIONS AND PROVIDE DETAIL AS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65403 25" OXYGEN CANNULA CANNULA, NASAL, OXYGEN CAT WESTMED, INC. 0551-TN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention