INJ. OPTIV DH,SI W/OEM

Description of Event or Problem

THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2026. THE CUSTOMER STATES THAT AT 8:30 A.M. ON (B)(6) 2026, PATIENT UNDERWENT LOWER LIMB CTA EXAMINATION. WITH THE CONTRAST MEDIUM FLOW RATE SET AT 1.0, THE SLEEVE OF THE HIGH-PRESSURE INJECTOR RUPTURED. AFTER THE ABNORMALITY WAS DETECTED, THE SLEEVE WAS REPLACED IMMEDIATELY TO CONTINUE THE EXAMINATION. THE INCIDENT CAUSED THE PATIENT TO FEEL FRIGHTENED, AND THE REPEATED EXAMINATION RESULTED IN INCREASED RADIATION EXPOSURE. THE FAULTY DEVICE WAS IMMEDIATELY DISCONTINUED AND REPLACED, AND THE EXAMINATION WAS FINALLY COMPLETED.