STELLANT DUAL CT INJECTOR

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 43-YEAR-OLD FEMALE UNDERGOING A CT OF THE CHEST HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). FOLLOWING COMPLETION OF THE PROCEDURE, THE CUSTOMER REPORTED THAT APPROXIMATELY 40 ML OF AIR WAS VIEWED ON THE DISPLAYED IMAGES. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND IS REPORTED AS BEING STABLE.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES USED DURING THE PROCEDURE; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THE MEDRAD® STELLANT FLEX INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD; SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.