RUSCH BRONCHOPART DOUBLE LUMEN RIGHT

Additional Manufacturer Narrative

(B)(4).

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."

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). THE REPORTED ISSUE 'CUFF LEAKAGE PRIOR TO USE' WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED AN ACTUAL SAMPLE FOR INVESTIGATION. BASED ON VISUAL INSPECTION IT WAS CONFIRMED THE DEFECT OBSERVED ON THE CUFF OF THE TRACHEAL TUBE IS A VISIBLE TEAR OR RUPTURE. FUNCTIONAL TESTING, PERFORMED BY IMMERSING THE TUBE IN WATER AND INFLATING THE CUFF, AIR BUBBLES WERE OBSERVED COMING OUT FROM THE TEAR, CONFIRMING THE LEAK. THE EDGES OF THE TEAR ARE IRREGULAR AND FRAYED POSSIBILITY DUE TO MECHANICAL STRESS THAT OCCURRED POST MANUFACTURING AS THE PRODUCT UNDERGOES 100% LEAK TESTING DURING PRODUCTION. A DEVICE HISTORY RECORD (DHR) WAS REVIEWED; NO ISSUE RELATED TO COMPLAINT WAS NOTED. ADDITIONALLY, THE WARNINGS AND NOTES IN IFU MENTION THAT "VARIOUS BONY ANATOMICAL STRUCTURES (E. G. TEETH) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION AID WITH SHARP SURFACES CAN DAMAGE THE INTEGRITY OF THE CUFF. CARE MUST BE TAKEN TO AVOID DAMAGING THE THIN-WALLED CUFF DURING INTUBATION, WHICH COULD RESULT IN THE PATIENT REQUIRING THE TRAUMA OF EXTUBATION AND RE-INTUBATION. IF THE CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED.". THE ROOT CAUSE OF THE DEFECT COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.