SUNMED

Additional Manufacturer Narrative

ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 HAS BEEN INCLUDED IN THIS 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 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 AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

Description of Event or Problem

THE AREA WHERE THE PILOT BALLOON MEETS THE TUBE IS NARROWED, SO MUCH THAT A SUCTION CATHETER CANNOT BE PASSED THROUGH CAUSING SAFETY CONCERNS.

Description of Event or Problem

THE AREA WHERE THE PILOT BALLOON MEETS THE TUBE IS NARROWED, SO MUCH THAT A SUCTION CATHETER CANNOT BE PASSED THROUGH CAUSING SAFETY CONCERNS.

Additional Manufacturer Narrative

ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 HAS BEEN INCLUDED IN THIS 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 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 AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE COMPLAINT REPORTED "THE AREA WHERE THE PILOT BALLOON MEETS THE TUBE IS NARROWED, SO MUCH THAT A SUCTION CATHETER CANNOT BE PASSED THROUGH CAUSING SAFETY CONCERNS." THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. BASED ON THE COMPLAINT REPORT NO PATIENT WAS AFFECTED. THERE WERE NO PHOTO IMAGES, VIDEOS OR RETURNED SAMPLE OF THE REPORTED ISSUE; THEREFORE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED. AN INVENTORY ASSESSMENT WAS CONDUCTED FOR PART NUMBER 1-7333-25. HOWEVER, THE INVENTORY FROM THE REPORTED LOT (2306011372) WAS NOT AVAILABLE; THEREFORE, WE SELECTED INVENTORY FROM A DIFFERENT LOT FOR EVALUATION. BASED ON THE RESULTS FROM THE VISUAL INSPECTION PERFORMED AT GRAND RAPIDS, THE RESULTS SHOWED THAT THE TUBE DIAMETERS WERE WITHIN NORMAL PARAMETERS. THE COMPLAINT HISTORY WAS REVIEWED FOR THE 24 MONTHS BEFORE THE COMPLAINT REPORTING DATE FOR PART 1-7333-25. NO COMPLAINTS WITH SIMILAR ISSUES WERE DETECTED, THIS IS THE FIRST REPORTING COMPLAINT FOR PART NUMBER 1-7333-25. PER THE RISK ASSESSMENT PERFORMED IN THE ACTIVITY LOG, THE RISK DETERMINATION (MEDIUM) INDICATES THAT THE COMPLAINT NEEDS TO BE SUBMITTED TO THE CAPA REVIEW BOARD. ADDED TO CARB (B)(6) 2024. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.