RUSCH BRONCHOPART DOUBLE LUMEN LEFT
Received Dec 17, 2025 · Event occurred Nov 21, 2025
Report 8040412-2025-00271 · MDR key 23827306
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalCatalog number
116100-000350
Lot number
KME22M1580
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED "THE HCPS HAVE IDENTIFIED THE LEAKAGE IN THE TRACHEAL CUFF & BRONCHIAL CUFF IN EACH UNIT RESPECTIVELY PRIOR TO USE ON A PATIENT". NO PATIENT INVOLVEMENT REPORTED. PLEASE SEE THE ASSOCIATED MDR # 8040412-2025-00270.
Additional Manufacturer Narrative
(B)(4) NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION; ONLY A PHOTO WAS PROVIDED. THE IMAGE INCLUDED TWO PRODUCTS FROM THE SAME LOT NUMBER, SIZE CH. 35. EACH PRODUCT IN THE PHOTO WAS ACCOMPANIED BY NOTES. ONE PRODUCT WAS IDENTIFIED AS HAVING A BRONCHIAL CUFF LEAK, WHILE THE OTHER WAS NOTED TO HAVE A TRACHEAL CUFF LEAK. BASED ON THE PHOTO, THE PRODUCT LABELED AS HAVING A TRACHEAL CUFF LEAK APPEARS TO HAVE ITS BRONCHIAL CUFF INFLATED WHILE THE TRACHEAL CUFF DEFLATED, WHEREAS THE PRODUCT LABELED WITH A BRONCHIAL CUFF LEAK SHOWS BOTH THE TRACHEAL AND BRONCHIAL CUFFS DEFLATED. DUE TO THE SAMPLE NOT BEING RETURNED, A PHYSICAL INVESTIGATION OF THE LEAKAGE COULD NOT BE CON-DUCTED. THEREFORE, THE INVESTIGATION IS LIMITED TO VISUAL ASSESSMENT BASED ON THE PHOTO PROVIDED AND UNABLE TO CONFIRM THE LEAK BASED ON THE PHOTO. THE DEVICE HISTORY RECORD FOR LOT WAS RE-VIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. NO SAMPLE WAS RETURNED FOR INVESTIGATION; ONLY A PHOTO WAS PROVIDED. THEREFORE, THE INVESTIGATION WAS LIMITED TO A VISUAL ASSESSMENT BASED ON THE PHOTO. THE IMAGE SHOWED TWO PRODUCTS WITH NOTES, ONE LABELED AS TRACHEAL CUFF LEAK WITH THE BRONCHIAL CUFF INFLATED AND TRACHEAL CUFF DEFLATED, AND THE OTHER LABELED AS BRONCHIAL CUFF LEAK WITH BOTH CUFFS DEFLATED. HOWEVER, THIS COULD NOT BE CONFIRMED WITHOUT THE RETURN OF THE PHYSICAL SAMPLES. UNABLE TO CONFIRM THE LEAKAGE DUE TO SAM-PLE IS NOT AVAILABLE.
Description of Event or Problem
IT WAS REPORTED "THE HCPS HAVE IDENTIFIED THE LEAKAGE IN THE TRACHEAL CUFF & BRONCHIAL CUFF IN EACH UNIT RESPECTIVELY PRIOR TO USE ON A PATIENT". NO PATIENT INVOLVEMENT REPORTED. PLEASE SEE THE ASSOCIATED MDR #8040412-2025-00270.