RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Additional Manufacturer Narrative

(B)(4). ONE (1) ACTUAL SAMPLE RECEIVED FOR INVESTIGATION; IT WAS RETURNED TOGETHER WITH THE SWIVEL BLUE ANGULAR CONNECTOR, SWIVEL TRANSPARENT ANGULAR CONNECTOR AND Y-CONNECTOR. THE LOT NUMBER PRINTED ON THE PROVIDED LABEL WAS VERIFIED AS 40E25C0523 FOR FINISHED GOOD PRODUCT CODE 116100, SIZE 41. NO VISUAL ABNORMALITIES WERE NOTED ON THE RETURNED SAMPLE DURING INITIAL INSPECTION. UPON FUNCTIONAL INSPECTION PERFORMED, THE TEAR LOCATION WAS FURTHER INVESTIGATE USING KEYENCE DIGITAL MICROSCOPE. THE TRACHEAL CUFF SHOWS A VISIBLE JAGGED, IRREGULAR TEAR WITH SHARP AND CLEAN EDGES. THIS SUGGESTS THE DAMAGE WAS CAUSED BY STRONG PRESSURE IN ONE SPOT, CONSISTENT WITH MECHANICAL CLAMPING OR PRESSING ON THE CUFF. ACCORDING TO BRONCHIAL MANUFACTURING PROCEDURE (LEFT AND RIGHT SIDE BRONCHIAL) THE PRODUCT UNDERGONE LEAK TEST 100% INSPECTION. THE COMPLAINT IS CONFIRMED AS PER COMPLAINT EVENT DESCRIPTION; HOWEVER THE ROOT CAUSE OF THE LEAK COULD NOT BE DETERMINED AS THE DEFECT WAS FOUND DURING CUSTOMER PRETEST. FUNCTIONAL TESTING WAS PERFORMED BY INFLATING THE BRONCHIAL CUFF WITH BLUE PILOT BALLOON AND TRACHEAL CUFF WITH COLOURLESS PILOT BALLOON AS PER IFU. BOTH CUFFS WERE INITIALLY ABLE TO BE INFLATED, HOWEVER, THE BRONCHIAL CUFF MAINTAINED ITS INFLATED SHAPE, WHILE THE TRACHEAL CUFF GRADUALLY DEFLATED AFTER INFLATION. A LEAK TEST WAS PERFORMED ON THE TRACHEAL CUFF BY IMMERSING THE TUBE IN WATER AND REINFLATING THE CUFF. AIR BUBBLES WERE OBSERVED COMING OUT FROM THE WATER INDICATING THE PRESENCE OF LEAK AND LEAKAGE AREA HAS BEEN IDENTIFIED. WARNINGS AND NOTES IN IFU, MENTION THAT "V ARIOUS 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." VISUAL INSPECTION OF THE RETURNED COMPLAINT SAMPLE CONFIRMED THE PRESENCE OF A TEAR THAT CAUSED THE CUFF LEAKAGE. HOWEVER, THE ROOT CAUSE OF THE DEFECT COULD NOT BE DETERMINED. THEREFORE, CORRECTIVE ACTION IS NOT REQUIRED AS PART OF THIS COMPLAINT INVESTIGATION AS THE ROOT CAUSE IS UNDETERMINED. BASED ON VISUAL INSPECTION IT WAS CONFIRMED THE DEFECT OBSERVED ON THE CUFF OF THE TRACHEAL TUBE IS A VISIBLE TEAR. 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 TEAR EXHIBITED JAGGED AND IRREGULAR WITH SHARP AND CLEAN EDGES. THIS SUGGESTS THE DAMAGE WAS CAUSED BY STRONG PRESSURE IN ONE SPOT, CONSISTENT WITH MECHANICAL CLAMPING OR PRESSING ON THE CUFF THAT OCCURRED POST MANUFACTURING AS THE PRODUCT UNDERGOES 100% LEAK TESTING DURING PRODUCTION. THE ROOT CAUSE OF THE DEFECT COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD (DHR) WAS REVIEWED; NO ISSUE RELATED TO COMPLAINT WAS NOTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT "WHEN TESTING THE TUBE BEFORE INSERTION, WE NOTICED A LEAK IN THE TRACHEAL CUFF (WHITE). DEVICE WAS CHANGED." NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "WHEN TESTING THE TUBE BEFORE INSERTION, WE NOTICED A LEAK IN THE TRACHEAL CUFF (WHITE). DEVICE WAS CHANGED." NO PATIENT INVOLVEMENT.