RUSCH BRONCHOPART DLT LEFT, CARINA HOOK

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 NOT ABLE TO BE PERFORMED DUE TO NO LOT NUMBER BEING REPORTED. 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.

Description of Event or Problem

IT WAS REPORTED THAT " AN INCIDENT OCCURRED ON (B)(6) 2026. THERE WAS A LOSS OF PRESSURE IN THE TRACHEAL CUFF OF THREE DIFFERENT TUBES OF THE SAME REF. ANOTHER TUBE WITH A DIFFERENT REFERENCE WAS USED INSTEAD. THIS IS THE FIRST TIME THIS EVENT HAS OCCURRED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE DEVICE COULD NOT BE RETRIEVED. CURRENT PATIENT STATUS: NO OBVIOUS DENTAL TRAUMA DURING THE PROCEDURE." ASSOCIATED COMPLAINTS: 8040412-2026-00033,8040412-2026-00034 AND 8040412-2026-00035.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT " AN INCIDENT OCCURRED ON (B)(6) 2026. THERE WAS A LOSS OF PRESSURE IN THE TRACHEAL CUFF OF THREE DIFFERENT TUBES OF THE SAME REF. ANOTHER TUBE WITH A DIFFERENT REFERENCE WAS USED INSTEAD. THIS IS THE FIRST TIME THIS EVENT HAS OCCURRED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE DEVICE COULD NOT BE RETRIEVED. CURRENT PATIENT STATUS: NO OBVIOUS DENTAL TRAUMA DURING THE PROCEDURE." ASSOCIATED COMPLAINTS: 8040412-2026-00033,8040412-2026-00034.