MalfunctionBTR
ENDOTRACHEAL TUBE, 2.5 CUFFED
Received Aug 7, 2025 · Event occurred Jul 16, 2025
Report MW5174207 · MDR key 22741655
Device
Generic name
Tube, Tracheal (w/wo Connector)
Manufacturer
Sunmed Group Holdings, Llc Dba AirlifeModel number
1-7333-25Lot number
2402010378
Product problems
- Product Quality Problem
- Failure to Advance
- Device-Device Incompatibility
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE ENDOTRACHEAL TUBE MADE BY SUNMED LLC, CUFFED ENDOTRACHEAL TUBE, SIZE 2.5. A NEWER SHIPMENT WILL NOT ACCEPT A SIZE 5/6 SUCTION CATHETER. THIS HAS BEEN A CHANGE FROM PRIOR PRODUCT AND IS A PROBLEM AS ENDOTRACHEAL TUBE OBSTRUCTION CAN CAUSE DEATH. PHOTO 1 HAS THE OLD ETT WITH ABILITY TO PASS SUCTION, PHOTOS 2 AND 3 DEMONSTRATE THAT THE SUCTION WILL NOT PASS BEYOND THE MID PORTION OF THE ETT WHERE THE PILOT BALLOON IS INSERTED.