RUSCH BRONCHOPART DOUBLE LUMEN RIGHT
Received Jan 6, 2026 · Event occurred Dec 11, 2025
Report 8040412-2026-00006 · MDR key 23972869
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalCatalog number
116200-000350
Lot number
KME22D1321
Product problems
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 COMPLAINT OF CUFF LEAKAGE COULD NOT BE CONFIRMED BASED UPON THE INVESTIGATION OF THE SAMPLE RECEIVED. THE CUSTOMER RETURNED AN ACTUAL SAMPLE FOR INVESTIGATION. BASED ON VISUAL INSPECTION AND FUNCTIONAL TEST ON ACTUAL RETURNED SAMPLE, NO DEFECT WAS OBSERVED ON SAMPLE AND NO PROBLEM FOUND ON THE SAMPLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. BASED ON THE INVESTIGATION OF THE RETURNED COMPLAINT DEVICE, NO ISSUES WERE FOUND.