RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Description of Event or Problem

IT WAS REPORTED THAT "ACCORDING TO [DOCTOR], A PATIENT WAS IN FOR A THORACIC PROCEDURE, THE FIRST BRONCHIAL TUBE WAS INSERTED WITHOUT PRIOR CHECKING OF THE CUFF, AFTER INSERTION IT WAS FOUND TO BE LEAKING. A SECOND ONE WAS CHECKED FOR LEAKAGE PRIOR AND FOUND TO BE OK WITH NO LEAK, AFTER CAREFUL INSERTION, IT WAS FOUND TO BE LEAKING AS WELL. AND THE THIRD TUBE, SIZE 39, TOO AFTER IT WAS INSPECTED FOR LEAKAGE, CAREFULLY INSERTED BUT WAS FOUND TO BE LEAKING FROM THE CUFF - ONLY THE FOURTH TUBE WAS SUCCESSFULLY INSERTED".

Additional Manufacturer Narrative

QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "ACCORDING TO [DOCTOR], A PATIENT WAS IN FOR A THORACIC PROCEDURE, THE FIRST BRONCHIAL TUBE WAS INSERTED WITHOUT PRIOR CHECKING OF THE CUFF, AFTER INSERTION IT WAS FOUND TO BE LEAKING. A SECOND ONE WAS CHECKED FOR LEAKAGE PRIOR AND FOUND TO BE OK WITH NO LEAK, AFTER CAREFUL INSERTION, IT WAS FOUND TO BE LEAKING AS WELL. AND THE THIRD TUBE, SIZE 39, TOO AFTER IT WAS INSPECTED FOR LEAKAGE, CAREFULLY INSERTED BUT WAS FOUND TO BE LEAKING FROM THE CUFF - ONLY THE FOURTH TUBE WAS SUCCESSFULLY INSERTED".