VENTURI MASK KIT ADULT

Additional Manufacturer Narrative

EXPIRATION DATE- 04/2020. MANUF. DATE- 04/2015. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. A RETURN SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE COULD NOT CONFIRM A DISCREPANCY IN THE PRODUCT. AFTER A DETAILED REVIEW OF BATCH RECORDS FOR THE PRODUCT AND LOT, NO DISCREPANCIES (INCLUDING NON-CONFORMANCES/DEVIATIONS) WERE FOUND. THE EVALUATION OF STOCK SAMPLES INDICATED THAT ADJUSTABLE DILUTER PERFORMED AS INTENDED AND MEETS THE SPECIFICATION REQUIREMENTS. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THE COMPLAINT WILL BE CLOSED. FURTHER PATIENT/EVENT INFORMATION WAS REQUESTED ALTHOUGH NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE "OXYGEN FLOW DOES NOT NORMALIZE AS INDICATED. AT THE SMALLEST INSPIRED OXYGEN FRACTION, THE FLOW IS HIGHER AND THE LOWER FLOW FRACTION INCREASES." NO PATIENT HARM RESULTED DUE TO THE REPORTED MALFUNCTION.

Additional Manufacturer Narrative

ADDITIONALLY, MFR REPORT# 9680866-2016-00065 AND MFR REPORT# 9680866-2016-00066 WHICH WERE SUBMITTED ON 02/25/2016, ARE FOR THE SAME PATIENT AND THESE COMPLAINT RECORDS ARE ASSOCIATED WITH EACH OTHER. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).