SUNMED

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.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 10 OCT 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.