FISHER AND PAYKEL HEALTHCARE

Additional Manufacturer Narrative

(B)(6). SECTION G4: PMA/510(K) NUMBER - NO 510(K) NUMBER INCLUDED DUE TO THE SUBJECT DEVICE BEING EXEMPT FROM PMS PATHWAY TO REGULATORY APPROVAL. METHOD: THE SUBJECT DEVICE, OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION, PHOTOGRAPHY PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHY CONFIRMED THAT THE TUBING OF THE SUBJECT DEVICE WAS DETACHED AT THE CONNECTOR END (SWIVEL GRIP). CONCLUSION: BASED ON THE VISUAL INSPECTION OF THE PROVIDED PHOTO AND OUR KNOWLEDGE OF THE PRODUCT, IT IS MOST LIKELY THAT THE REPORTED EVENT RESULTED FROM THE SUBJECT DEVICE BEING SUBJECTED TO EXCESSIVE FORCE. AS PART OF THE MANUFACTURING PROCESS, ALL OPTIFLOW JUNIOR NASAL CANNULAS ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS IS DISCARDED. IN ADDITION, SAMPLES ARE TAKEN THROUGHOUT EACH BATCH AND FUNCTIONALLY TESTED FOR RETENTION STRENGTH BETWEEN THE ASSEMBLED PARTS. IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS PUT ASIDE FOR FURTHER INVESTIGATION. THE SUBJECT CANNULA WOULD HAVE MET THE REQUIRED SPECIFICATION AT TIME OF PRODUCTION. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: - APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH. - DO NOT STRETCH OR CRUSH TUBE. - ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED. UNDER EXCESSIVE LOAD, THE CANNULA MAY DISCONNECT TO PREVENT FORCES BEING TRANSFERRED TO THE PATIENT.

Description of Event or Problem

A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WERE NO REPORTED PATIENT INVOLVEMENT.