STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTOR, SERIAL NUMBER (B)(6), WAS COMPLETED ON OCTOBER 23 2025 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THERE WAS NO EVIDENCE OF EQUIPMENT MALFUNCTION. THE STELLANT DISPOSABLE SET THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE AND UNAVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES USED DURING THE INCIDENT; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN MADE TO THE CUSTOMER AND WAS DECLINED. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: VESSEL HAZARD - SERIOUS PATIENT INJURY MAY RESULT. FOLLOW INSTITUTIONAL EXTRAVASATION MINIMIZING TECHNIQUES. A SMALL VOLUME TEST INJECTION MAY BE UTILIZED TO CONFIRM VENOUS ACCESS. IT IS RECOMMENDED THAT THE OPERATOR STAY BY THE PATIENT'S SIDE AT THE BEGINNING OF THE INJECTION AND TO INSTRUCT THE PATIENT TO COMMUNICATE IMMEDIATELY ANY PAIN OR CHANGE IN FEELING DURING THE INJECTION. CHECK FOR EXTRAVASATION OF CONTRAST OR SALINE DURING INJECTION. IF AN EXTRAVASATION IS DETECTED, STOP THE INJECTION AND REFER TO RESPECTIVE FACILITY POLITY REGARDING TREATMENT. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THE FOLLOWING: A PATIENT WAS UNDERGOING AN ENHANCED CT SCAN OF THE ABDOMEN WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). DURING THE EXAMINATION, THE TECHNOLOGIST NOTED THAT THERE WAS NO CONTRAST ON THE IMAGES DISPLAYED. THE PATIENT WAS EVALUATED AND FOUND THAT APPROXIMATELY 100ML OF CONTRAST HAD EXTRAVASATED AT THE LEFT ANTECUBITAL INJECTION SITE. A COLD COMPRESS WAS APPLIED TO THE AFFECTED LIMB, AND THE PATIENT WAS REFERRED TO A PLASTIC SURGEON FOR CONSULTATION. THE PATIENT WAS REPORTED TO HAVE RECOVERED AFTER THE CONSULTATION; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.