RUSCH TRACHEAL TUBE, CUFFED, NASAL PREFORMED
Received Jul 28, 2025 · Event occurred Jun 25, 2025
Report 8040412-2025-00186 · MDR key 22635871
Device
Generic name
Stylet, Tracheal Tube
Manufacturer
Teleflex Medical Sdn. Bhd.Catalog number
111782-000070
Lot number
40E25A3258
Product problems
- Inflation Problem
- Inflation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 THAT "THE CUFF COULD NOT BE INFLATED DURING THE INFLATION SYSTEM TEST.".
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "THE CUFF COULD NOT BE INFLATED DURING THE INFLATION SYSTEM TEST."