SUNMED

Additional Manufacturer Narrative

THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC EVIDENCE. ANALYSIS OF THE PHOTO CONFIRMED THE REPORTED COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. THERE HAVE BEEN 2 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A REVIEW OF COMPLAINT HISTORY IDENTIFIED TWO ADDITIONAL COMPLAINTS INVOLVING THE SAME PART NUMBER AND A SIMILAR FAILURE MODE WITHIN THE PRECEDING 24 MONTHS. NO ADDITIONAL TRENDS WERE IDENTIFIED; MONITORING WILL CONTINUE FOR ANY EMERGING TRENDS. THE DEVICE HISTORY RECORD FOR LOT 2205010833 WAS REVIEWED, AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 10 APR 2026 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 (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.

Description of Event or Problem

IT WAS REPORTED THAT THE 2.5 MM CUFFED ENDOTRACHEAL TUBE (ETT) DID NOT ALLOW PASSAGE OF THE 5/6 FRENCH SUCTION CATHETER. ON (B)(6), 2026, IT WAS FURTHER NOTED THAT THE EVENT WAS ASSOCIATED WITH PATIENT ISSUES REQUIRING EXTUBATION AND REINTUBATION.