F&P FLEXITRUNK

Description of Event or Problem

A DISTRIBUTOR IN MALAYSIA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS TORN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

(b)(6).METHOD: THE SUBJECT BC191-05 FLEXITRUNK NASAL TUBING WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P). OUR INVESTIGATION IS THUS BASED ON THE INFORMATION, PROVIDED BY THE HEALTHCARE FACILITY INCLUDING VIDEOGRAPHY, AND OUR KNOWLEDGE OF THE PRODUCT.RESULTS: VISUAL INSPECTION OF THE PROVIDED VIDEOGRAPHY CONFIRMED THAT ONE OF THE TUBES OF THE DEVICE WAS TORN. CONCLUSION: WE ARE UNABLE TO CONFIRM THE CAUSE OF THE REPORTED EVENT. AS PART OF THE MANUFACTURING PROCESS, EACH FLEXITRUNK INFANT NASAL TUBING DEVICE UNDERGOES VISUAL INSPECTION AND LEAK TESTING. DEVICES THAT DO NOT MEET THE SPECIFICATIONS ARE REJECTED AND NOT RELEASED FOR DISTRIBUTION.THE USER INSTRUCTIONS WHICH ACCOMPANY THE BC191-05 FLEXITRUNK NASAL TUBING INCLUDE THE FOLLOWING:- "HANDLE WITH CARE. USE CAUTION WHEN POSITIONING OR DISCONNECTING TO THE INFANT INTERFACE. AVOID EXCESSIVE PULL FORCES, SHARP OBJECTS, AND TUBING HOLDERS. DAMAGE TO THE TUBING MAY CAUSE LOSS OF PRESSURE AND REQUIRE IMMEDIATE REPLACEMENT."- "DISCONNECT THE FLEXITRUNK INTERFACE GENTLY BY TWISTING THE CONNECTORS. DO NOT PULL FORCEFULLY, AS THIS MAY DAMAGE THE TUBING. HANDLE WITH CARE"- "USE PATIENT OXYGEN MONITORING"ADDITIONALLY, A CAUTION INSERT IS INCLUDED IN THE PACKAGING TO REMIND THE USER TO TAKE EXTRA CARE WHEN HANDLING THE BC191-05 FLEXITRUNK NASAL TUBING.SECTION G4: PMA/510(K) NUMBER - NO 510(K) NUMBER INCLUDED DUE TO THE SUBJECT DEVICE BEING EXEMPT FROM PMS PATHWAY TO REGULATORY APPROVAL.