ULRICH MEDICAL

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS RESPONSE, ULRICH UNDERSTANDS THAT A SINGLE PATIENT WAS CONNECTED TO BOTH THE ULRICHINJECT CT MOTION TUBING SYSTEM AND A SEPARATE INTRAVENOUS (IV) LINE DURING A COMPUTED TOMOGRAPHY (CT) PROCEDURE. FOLLOWING THE CT PROCEDURE, A NON-LIFE-THREATENING VOLUME OF AIR WAS APPARENT IN THE RESULTING CARDIAC CT IMAGES. THE USE OF THE SEPARATE IV LINE IS AN ADDITIONAL FLUID PATHWAY THAT IS NOT PART OF THE DEFINED AND VALIDATED INJECTOR TUBING SYSTEM. PER THE ULRICHINJECT CT MOTION INSTRUCTIONS FOR USE, ONLY THE SPECIFIED TUBING CONFIGURATION IS WITHIN THE DEVICES INTENDED USE, WHEREAS ADDITIONAL EXTENSION LINES OR EXTERNAL FLUID PATHS ARE NOT COVERED BY THE INJECTOR'S AIR DETECTION AND SAFETY MECHANISMS (IFU SECTION 5.2).

Description of Event or Problem

INFORMED OF POSSIBLE AIR INJECTION (B)(6) 2026 AT 09:50. RECEIVED A REPORT THAT A PATIENT WAS INJECTED WITH A SMALL AMOUNT OF AIR. NO FURTHER INFORMATION AT THIS TIME.