RUSCH BRONCHOPART DLT LEFT, CARINA HOOK
Received Sep 19, 2025 · Event occurred Aug 14, 2025
Report 8040412-2025-00231 · MDR key 23094002
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalModel number
IPN047059Catalog number
116101-000410
Lot number
40E24J4876
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
QN# (B)(4).
Description of Event or Problem
IT WAS REPORTED BY THE HEALTH CARE FACILITY THAT: "THE TIP (LUG) OF THE CARLENS 41 TUBE WAS AGAINST THE BALLOON AND DID NOT DEPLOY DURING INTUBATION, EVEN WITH THE BRONCHIAL FIBERSCOPE.".
Additional Manufacturer Narrative
QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED BY THE HEALTH CARE FACILITY THAT: "THE TIP (LUG) OF THE CARLENS 41 TUBE WAS AGAINST THE BALLOON AND DID NOT DEPLOY DURING INTUBATION, EVEN WITH THE BRONCHIAL FIBERSCOPE."