CO2 CANNULA,SSOFT,ADLT,7O2,7CO2,M,BLK

Additional Manufacturer Narrative

INVESTIGATION OF THE SAMPLES RETURNED TO THE MANUFACTURER HAS BEEN COMPLETED. THE RETURNED SAMPLES WERE FROM LOT NUMBER 40020070113. UPON VISUAL INSPECTION, THE RETURNED SAMPLES APPEARED TO BE IN NEW CONDITION. TO DATE, NO ADDITIONAL INFORMATION RELATED TO THE USE OF THE PRODUCT OR THE REPORTED DE-SATURATION INCIDENT HAS BEEN RECEIVED BY THE MANUFACTURER. IT IS UNKNOWN IF PRODUCT FROM LOT NUMBER 40020070113 WAS INVOLVED IN THE REPORTED DE-SATURATION INCIDENT. MODEL NUMBER HCS4568BS IS MADE OF MATERIAL THAT IS NOT KINK-RESISTANT AS IT IS ONLY INTENDED TO MAKE SOFT ROUND TURNS UNDER THE CHIN AND BEHIND THE EARS TO UNDER THE NOSE. THE REPORTED PRODUCT PROBLEM/ISSUE WAS UNABLE TO BE CONFIRMED UPON COMPLETION OF THE SAMPLE INVESTIGATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TUBING OF THE CO2 CANNULA KINKED DURING AN UNSPECIFIED EYE PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED DE-SATURATION. DESPITE MULTIPLE GOOD FAITH ATTEMPTS, THE REPORTING FACILITY WAS UNABLE OR UNWILLING TO PROVIDE ADDITIONAL INFORMATION TO THE MANUFACTURER. NO ADVERSE PATIENT IMPACT OR MEDICAL INTERVENTION WAS ORIGINALLY REPORTED. A SAMPLE WAS RETURNED TO THE MANUFACTURER. SAMPLE EVALUATION IS ONGOING AT THIS TIME. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBING OF THE CO2 CANNULA KINKED.