MalfunctionBTS
RUSCH BRONCHOPART DOUBLE LUMEN LEFT
Received Jul 3, 2026 · Event occurred Jun 1, 2026
Report 8040412-2026-00105 · MDR key 25705107
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Product code (BTS)
Manufacturer (Teleflex Medical Llc)
Model (IPN047053)
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalModel number
IPN047053Catalog number
116100-000370
Lot number
40E26A0022
Product problems
- Nonstandard Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "VERY NARROW ENTRANCE IN THE TRACHEAL ENTRANCE OF THE TUBE. SO IT WAS NOT POSSIBLE TO INSERT THE FIBER THROUGH THE WHITE PART OF THE DLT. IT LOOKS LIKE THE WHITE PART IS A BIT COMPRESSED." SWITCHED TO ANOTHER DLT TO PROCEED WITH THE PROCEDURE. NO PATIENT INJURY OR CONSEQUENCES REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".