RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."

Additional Manufacturer Narrative

(B)(4).

Additional Manufacturer Narrative

(B)(4). THE REPORTED COMPLAINT OF CUFF LEAKAGE WAS CONFIRMED BASED UPON THE INVESTIGATION OF THE SAMPLE RECEIVED. THE CUSTOMER RETURNED THE ET TUBE FOR INVESTIGATION. FUNCTIONAL TESTING, PERFORMED BY IMMERSING THE TUBE IN WATER AND INFLATING THE CUFF, REVEALED AIR BUBBLES COMING OUT FROM THE HOLE, CONFIRMING THE LEAK. UPON FURTHER INSPECTION, A TEAR WAS LOCATED ON THE BRONCHIAL CUFF WITH CLEAN CUT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. A REVIEW OF THE MANUFACTURING PROCESS CONFIRMED THAT THESE TUBES UNDERGO 100% LEAK TESTING DURING PRODUCTION AS PART OF PRODUCT RELEASE CRITERIA. ANY INEFFECTIVE PRODUCTS WILL BE CULLED OUT DURING THIS PROCESS. BASED ON THE INVESTIGATION, THE EXACT ROOT CAUSE OF THIS REPORTED ISSUE WAS UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE".