BALLARD CLOSED SUCTION SYSTEM

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 JUNE 2026 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 INFORMATION KNOWN 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 PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND 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 WAS DEFECTIVE OR CAUSED SERIOUS INJURY.

Description of Event or Problem

IT WAS REPORTED THAT THE NURSE PRACTITIONER (NP) OBSERVED A FLAPPER VALVE LODGED IN THE CATHETER MOUNT ON MULTIPLE OCCASIONS. THERE WAS NO REPORTED DELAY IN THERAPY, SERIOUS HARM, OR INJURY ASSOCIATED WITH THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT REFERENCING MULTIPLE INCIDENTS ASSOCIATED WITH DIFFERENT PATIENTS OR UNITS. THIS IS THE SECOND OF THREE RELATED REPORTS. REFER TO 8030647-2026-00036 FOR THE FIRST REPORT. REFER TO 8030647-2026-00038 FOR THE THIRD REPORT.