TRACHEAL TUBE, CUFFED
Received Jan 2, 2026 · Event occurred Dec 1, 2025
Report 8040412-2026-00001 · MDR key 23944202
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex Medical Sdn. Bhd.Model number
IPN041492Catalog number
112082-000075
Lot number
40E25F0346
Product problems
- Gas/Air Leak
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED VIA ANSM "IT WAS REPORTED THAT: THERE WAS A LEAK ISSUE WITH THE ET TUBE. WE CHANGED THE TUBE AND RE-INTUBATED THE PATIENT". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".
Additional Manufacturer Narrative
(B)(4).
Additional Manufacturer Narrative
(B)(4). SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT, AND NO PHOTO EVIDENCE IS AVAILABLE. HENCE, A VISUAL INVESTIGATION COULD NOT BE CONDUCTED. THE DEVICE HISTORY RECORD FOR LOT WAS REVIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THERE IS VERY LIMITED INFORMATION ON THE COMPLAINT AND FURTHERMORE NO PHYSICAL INVESTIGATION OR ASSESSMENT HAS BEEN CONDUCTED ON THE DEFECTIVE PART. 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 VIA ANSM "IT WAS REPORTED THAT: THERE WAS A LEAK ISSUE WITH THE ET TUBE. WE CHANGED THE TUBE AND RE-INTUBATED THE PATIENT". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".