RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Additional Manufacturer Narrative

(B)(4).

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 TO RESOLVE".

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 TO RESOLVE."

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. AN IRREGULAR, NON-UNIFORM SLIT WITH ROUGH AND UNEVEN EDGES. UNDER MAGNIFIED INSPECTION, THE DEFECT EXHIBITED A NON-UNIFORM, JAGGED MORPHOLOGY CONSISTENT WITH A MECHANICALLY INDUCED CUT RATHER THAN A PROCESS-DRIVEN FAILURE. THE ISOLATED NATURE OF THE TEAR AND THE ABSENCE OF MATERIAL OR PROCESS-RELATED INDICATORS STRONGLY SUGGEST THAT THE DEFECT RESULTED FROM EXTERNAL MECHANICAL DAMAGE. WITH THE AVAILABLE EVIDENCE, THE DEFECT IS UNLIKELY TO BE ASSOCIATED WITH ANY MANUFACTURING MATERIAL OR PROCESS ABNORMALITY. 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.