VITAL SIGNS

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 14 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 UPON INTUBATION, THE COATING OF THE STYLET BROKE OFF INSIDE THE ENDOTRACHEAL TUBE (ETT). THE ETT WAS REMOVED FROM THE AIRWAY, AND A NEW ETT AND STYLET WERE USED. PRE INTUBATION SPO2 WAS 78% ON 100% FIO2, RESULTING IN DELAYED INTUBATION. FOLLOWING REINTUBATION WITH A NEW STYLET AND ETT, FIO2 WAS WEANED TO 35%.