RUSCH BRONCHOPART DLT LEFT, CARINA HOOK
Received Jan 5, 2026 · Event occurred Dec 8, 2025
Report 8040412-2026-00002 · MDR key 23955917
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalModel number
IPN047059Catalog number
116101-000410
Lot number
40E24K1159
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, AFTER INSERTING THE TUBE, HE NOTICED A LEAK; UPON FURTHER INSPECTION, THE TRACHEAL CUFF WAS FOUND TO BE PUNCTURED. THE TUBE WAS DISCARDED. THERE WERE NO CONSEQUENCE FOR THE PATIENT; THE PROBLEM WAS RESOLVED BY USING A DIFFERENT TUBE'. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Additional Manufacturer Narrative
(B)(4). THERE IS VERY LIMITED INFORMATION ON THE COMPLAINT AND FURTHERMORE NO PHYSICAL INVESTIGATION OR ASSESSMENT HAS BEEN CONDUCTED ON THE DEFECTIVE PART. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. SINCE THERE WAS NO 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.
Description of Event or Problem
IT WAS REPORTED " AFTER INSERTING THE TUBE, HE NOTICED A LEAK; UPON FURTHER INSPECTION, THE TRACHEAL CUFF WAS FOUND TO BE PUNCTURED.THE TUBE WAS DISCARDED. THERE WERE NO CONSEQUENCE FOR THE PATIENT; THE PROBLEM WAS RESOLVED BY USING A DIFFERENT TUBE'. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".