RUSCH BRONCHOPART DOUBLE LUMEN LEFT
Received May 14, 2026 · Event occurred Apr 1, 2026
Report 8040412-2026-00070 · MDR key 25167992
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalCatalog number
116100-000350
Lot number
40E25B3203
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
(B)(4). ONE (1) ACTUAL SAMPLE WAS RECEIVED FOR INVESTIGATION. HOWEVER, THE ASSOCIATED COMPLAINT UNIT WAS NOT RETURNED; ONLY THE ACCESSORIES WERE PROVIDED. THE LOT NUMBER AND FINISHED PRODUCT CODE COULD NOT BE VERIFIED DUE TO THE ABSENCE OF ORIGINAL PACKAGING. CONSEQUENTLY, VISUAL INSPECTION OF THE COMPLAINT UNIT COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD FOR LOT 40E25B3203 WAS REVIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. CORRECTIVE ACTION IS NOT REQUIRED AS PART OF THIS COMPLAINT INVESTIGATION AS THE COMPLAINT CANNOT BE CONFIRMED WITHOUT RELATED SAMPLE RETURNED. THERE IS VERY LIMITED INFORMATION ON THE COMPLAINT AND FURTHERMORE NO PHYSICAL INVESTIGATION, OR ASSESSMENT HAS BEEN CONDUCTED ON THE DEFECTIVE PART. SINCE THERE WAS NO RELATED SAMPLE RETURNED FOR THIS COMPLAINT, FURTHER INVESTIGATION FOR THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED. THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT INVOLVEMENT.