MEDEX SMALL BORE EXTENSION SET W/ THREE-WAY STOPCOCK

Additional Manufacturer Narrative

THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER (B)(4). THE DATE OF THAT SUBMISSION WAS 07-FEB-2025. B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

Description of Event or Problem

IT WAS REPORTED THAT THE THREE-WAY STOPCOCKS ON THE A-LINES CAUSED MULTIPLE DISCONNECTIONS FROM THE A-LINES. THE CONNECTION WAS NOT SECURE ENOUGH AND COULD NOT BE MADE MORE SECURE LEADING TO DISCONNECTION. THE OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.