RUSCH BRONCHOPART DOUBLE LUMEN RIGHT
Received Oct 10, 2025 · Event occurred Aug 30, 2025
Report 8040412-2025-00243 · MDR key 23264513
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalCatalog number
116200-000350
Lot number
KME21C3438
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND BLUE BALLOON CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."
Additional Manufacturer Narrative
(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.
Description of Event or Problem
IT WAS REPORTED THAT: "ON (B)(6) 2025, THE DOCTOR FOUND BLUE BALLOON CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."
Additional Manufacturer Narrative
(B)(4).