MalfunctionCBI
ET TUBE, SHER-I-BRONCH, LS, 35 FR
Received Jul 13, 2026 · Event occurred May 7, 2026
Report 3003898360-2026-00297 · MDR key 25808408
Device
Generic name
Tube, Tracheal/bronchial, Diff
Manufacturer
Teleflex MedicalCatalog number
5-16035
Lot number
73G2400114
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 USING ON A PATIENT. CHANGED THE SECOND TUBE; THE SECOND TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A THIRD TUBE; THE THIRD TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A FOURTH TUBE, WHICH WAS USED NORMALLY." ASSOCIATED MDRS: 3003898360-2026-00323, 3003898360-2026-00295.