MEDRAD® STELLANT FLEX CT INJECTION SYSTEM WITH CENTEGRA WORKSTATION

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS NOTIFIED OF AN ALLEGED AIR EMBOLISM INVOLVING A 55-YEAR-OLD FEMALE PATIENT WITH AN ADMITTING DIAGNOSIS OF PLEURITIC CHEST PAIN WHO UNDERWENT A CTA EXAM USING A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (b)(6)). POST-PROCEDURE, THE RADIOLOGIST NOTED APPROXIMATELY 2 ML OF AIR IN THE PULMONARY TRUNK. NO MEDICAL INTERVENTION WAS REPORTED; HOWEVER, THE PATIENT WAS OBSERVED OVERNIGHT IN THE ICU. THE PATIENT REMAINED STABLE, WITH NO REPORTED COMPLICATIONS. THE CUSTOMER REPORTED NO LEAKAGE OR ABNORMALITIES DURING THE PROCEDURE OR DURING EQUIPMENT CHECKS PERFORMED BEFORE AND AFTER THE PROCEDURE. FOUR POTENTIAL LOT NUMBERS (8683700, 8682451, 8683725, AND 8670115) OF THE MEDRAD® STELLANT FLEX 150 ML STERILE DISPOSABLE SYRINGE KIT (FLEXD-150-SCS) WERE IN USE THAT DAY; HOWEVER, THE SPECIFIC LOT ASSOCIATED WITH THE ALLEGATION COULD NOT BE CONFIRMED.DURING A SUBSEQUENT RETROSPECTIVE EVALUATION OF DISPOSED SYRINGE TUBING, THE CUSTOMER IDENTIFIED ONE MEDRAD® STELLANT FLEX 150 ML STERILE DISPOSABLE SYRINGE KIT (FLEXD-150-SCS, LOT UNKNOWN) IN A WASTE RECEPTACLE WITH PARTIAL SEPARATION AT THE T-CONNECTOR. IT IS NOT CLEAR WHETHER THIS KIT WAS THE ONE IN USE DURING THE SUBJECT INCIDENT. AT THE TIME OF DISCOVERY, APPROXIMATELY ONE-QUARTER OF THE T-CONNECTOR (CONNECTING THE SALINE TUBING WITH THE CONTRAST TUBING) REMAINED INTACT, AND AIR BUBBLES WERE OBSERVED BETWEEN SYRINGES 1 AND 2. UPON FURTHER HANDLING, THE TUBING WAS NOTED TO BE FULLY SEPARATED. THE SUSPECT PRODUCT WAS NOT AVAILABLE FOR RETURN OR EVALUATION.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (B)(6) WAS COMPLETED ON (B)(6) 2026, BY A BAYER SERVICE REPRESENTATIVE, WHO CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. RETAINED SAMPLES FOR THE POTENTIAL REPORTED LOT NUMBERS HAVE BEEN ORDERED AND ARE UNDERGOING TESTING. THE INVESTIGATION REMAINS IN PROGRESS, AND A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION. 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

BAYER MEDICAL CARE INC. WAS NOTIFIED OF AN ALLEGED AIR EMBOLISM INVOLVING A 55-YEAR-OLD FEMALE PATIENT WITH AN ADMITTING DIAGNOSIS OF PLEURITIC CHEST PAIN WHO UNDERWENT A CTA EXAM USING A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (B)(6). POST-PROCEDURE, THE RADIOLOGIST NOTED APPROXIMATELY 2 ML OF AIR IN THE PULMONARY TRUNK. NO MEDICAL INTERVENTION WAS REPORTED; HOWEVER, THE PATIENT WAS OBSERVED OVERNIGHT IN THE ICU. THE PATIENT REMAINED STABLE, WITH NO REPORTED COMPLICATIONS. THE CUSTOMER REPORTED NO LEAKAGE OR ABNORMALITIES DURING THE PROCEDURE OR DURING EQUIPMENT CHECKS PERFORMED BEFORE AND AFTER THE PROCEDURE. FOUR POTENTIAL LOT NUMBERS (8683700, 8682451, 8683725, AND 8670115) OF THE MEDRAD® STELLANT FLEX 150 ML STERILE DISPOSABLE SYRINGE KIT (FLEXD-150-SCS) WERE IN USE THAT DAY; HOWEVER, THE SPECIFIC LOT ASSOCIATED WITH THE ALLEGATION COULD NOT BE CONFIRMED. DURING A SUBSEQUENT RETROSPECTIVE EVALUATION OF DISPOSED SYRINGE TUBING, THE CUSTOMER IDENTIFIED ONE MEDRAD® STELLANT FLEX 150 ML STERILE DISPOSABLE SYRINGE KIT (FLEXD-150-SCS, LOT UNKNOWN) IN A WASTE RECEPTACLE WITH PARTIAL SEPARATION AT THE T-CONNECTOR. IT IS NOT CLEAR WHETHER THIS KIT WAS THE ONE IN USE DURING THE SUBJECT INCIDENT. AT THE TIME OF DISCOVERY, APPROXIMATELY ONE-QUARTER OF THE T-CONNECTOR (CONNECTING THE SALINE TUBING WITH THE CONTRAST TUBING) REMAINED INTACT, AND AIR BUBBLES WERE OBSERVED BETWEEN SYRINGES 1 AND 2. UPON FURTHER HANDLING, THE TUBING WAS NOTED TO BE FULLY SEPARATED. THE SUSPECT PRODUCT WAS NOT AVAILABLE FOR RETURN OR EVALUATION.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (b)(6)) WAS COMPLETED ON (b)(6) 2026, BY A BAYER SERVICE REPRESENTATIVE, WHO CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. THE INJECTOR SYSTEM HAS REMAINED IN DAILY USE SINCE THE REPORTED OCCURRENCE. THE CUSTOMER DECLINED THE OFFER OF ADDITIONAL APPLICATIONS TRAINING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INJECTOR SYSTEM WAS MANUFACTURED IN ACCORDANCE WITH ESTABLISHED SPECIFICATIONS, WITH NO IDENTIFIED DEVIATIONS, NONCONFORMANCES, FAILURES, OR QUALITY-RELATED ISSUES. RETAINED SAMPLES FROM THE FOUR POTENTIAL LOT NUMBERS (8683700, 8682451, 8683725, AND 8670115) OF THE MEDRAD® STELLANT FLEX 150 ML STERILE DISPOSABLE SYRINGE KIT (FLEXD-150 SCS) WERE EXAMINED WITH NO ABNORMALITIES IDENTIFIED. THE MEDRAD® STELLANT FLEX INJECTION SYSTEM OPERATION MANUAL INCLUDES THE FOLLOWING WARNING:WARNING: AIR EMBOLISM HAZARD, SERIOUS PATIENT INJURY OR DEATH MAY RESULT"[LM1.1]".EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. CAREFULLY READ THE INSTRUCTIONS FOR LOADING AND THE USE OF THE SYRINGE BEACON AND MEDRAD® FLUIDOTS (WHERE APPLICABLE) TO REDUCE THE CHANCE OF AIR EMBOLISM.THE PRESENCE OF A SYRINGE BEACON OR ROUNDED FLUIDOTS DOES NOT INDICATE THE TOTAL ABSENCE OF AIR BUBBLES IN THE SYRINGE TIP. FLUIDOTS MUST BE VIEWED IN A PROPERLY ILLUMINATED ENVIRONMENT WITH A LIGHT SOURCE BEHIND THE OPERATOR PROVIDING ENOUGH LIGHT TO PERMIT EASY VIEWING.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.TO MINIMIZE THE POSSIBILITY OF INADVERTENT ASPIRATION AND INJECTION, ENSURE THE PATIENT IS DISCONNECTED FROM THE INJECTOR WHEN UTILIZING THE FORWARD AND REVERSE PISTON CONTROLS.THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.