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 COMPLAINT OF CUFF LEAKAGE WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE ACTUAL SAMPLE WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING CONFIRMED CUFF DEFLATION AFTER INFLATION. VISUAL EXAMINATION IDENTIFIED A TEAR LOCALIZED AND LINEAR, PRESENTING AS AN IRREGULAR SLIT WITH ROUGH, UNEVEN EDGES. UNDER MAGNIFIED INSPECTION, THE DEFECT DISPLAYED A SHARPLY DEFINED RUPTURE WITH BRANCHING FRACTURE LINES, CONSISTENT WITH A SUDDEN MECHANICAL CUT RATHER THAN A PROGRESSIVE MATERIAL FAILURE. BASED ON THE AVAILABLE EVIDENCE, THE DEFECT IS UNLIKELY TO BE RELATED TO A MANUFACTURING MATERIAL OR PROCESS ISSUE. THE COMPLAINT OF CUFF LEAKAGE IS CONFIRMED AND WAS ATTRIBUTED TO A CUT ON THE TRACHEAL CUFF. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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: "ON (B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."