STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTOR (SERIAL NUMBER (B)(6)) WAS COMPLETED ON JANUARY 29, 2026, AND CONFIRMED THAT THE EQUIPMENT WAS PERFORMING WITHIN BAYER SPECIFICATIONS. THE STELLANT DISPOSABLE SET USED DURING THE ALLEGED INCIDENT HAD BEEN DISCARDED BY THE SITE AND WAS UNAVAILABLE FOR EVALUATION. ADDITIONALLY, THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES IN USE AT THE TIME OF THE ALLEGATION, PREVENTING TESTING OF RETAINED SAMPLES. A DEVICE HISTORY RECORD (DHR) REVIEW IDENTIFIED NO EXCEPTIONS OR FAILURES IN THE MANUFACTURING OF THE INJECTOR SYSTEM. DOCUMENTED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INCIDENT AND TO PROVIDE APPLICATIONS SUPPORT WERE MADE ON JANUARY 12, 20, AND 26, 2026. TO DATE, THE CUSTOMER HAS NOT PROVIDED A WRITTEN RESPONSE TO THESE REQUESTS. ACCORDING TO THE BAYER SERVICE TEAM, THE MEDRAD® STELLANT CT INJECTOR SYSTEM REMAINS IN CLINICAL USE AT THE CUSTOMER SITE. THE MEDRAD® STELLANT CT 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. NOTE: THE INITIAL MDR SUBMISSION CONTAINED A DATA ENTRY ERROR. ALTHOUGH THE SERIAL NUMBER FOR THE MEDRAD® STELLANT CT INJECTOR WAS ENTERED CORRECTLY, THE CATALOG AND MODEL NUMBERS WERE ENTERED USING THE WRONG IDENTIFIERS. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE WAS INCORRECTLY STATED ON THE INITIAL MDR SUBMISSION AS JULY 2014. THE CORRECT MANUFACTURE DATE IS MAY 2014, WHICH PREDATES THE UDI IMPLEMENTATION DEADLINE OF SEPTEMBER 24, 2016, FOR CLASS II DEVICES. 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. RECEIVED A REPORT FROM THE FRENCH HEALTH AUTHORITY REGARDING A SUSPECTED AIR INJECTION INVOLVING AN 81 YEAR OLD PATIENT UNDERGOING A CT SCAN FOR ACUTE RESPIRATORY DISTRESS WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING ADMINISTRATION OF IODINATED CONTRAST, APPROXIMATELY 9ML OF AIR WAS OBSERVED IN THE MAIN PULMONARY ARTERY. THE PATIENT REMAINED CLINICALLY STABLE UNDER CLOSE OBSERVATION. SUPPLEMENTAL OXYGEN AT 8L/MIN WAS ADMINISTERED, AND NO DETERIORATION IN THE PATIENT'S OVERALL CONDITION WAS REPORTED. THE INCIDENT DESCRIPTION PROVIDED BY THE CUSTOMER TO THE FRENCH HEALTH AUTHORITY STATED: "THE PROFESSIONALS ARE UNABLE TO SPECIFY THE USAGE ERROR THAT LED TO THE INCIDENT, AT A TIME WHEN THEIR WORKLOADS ARE PARTICULARLY HEAVY."

Additional Manufacturer Narrative

THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS JULY 2014, WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF (B)(6) 2016, FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.

Description of Event or Problem

BAYER MEDICAL CARE INC. RECEIVED A REPORT FROM THE FRENCH HEALTH AUTHORITY REGARDING A SUSPECTED AIR INJECTION INVOLVING AN 81-YEAR-OLD PATIENT UNDERGOING A CT SCAN FOR ACUTE RESPIRATORY DISTRESS WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING ADMINISTRATION OF IODINATED CONTRAST, APPROXIMATELY 9 ML OF AIR WAS OBSERVED IN THE MAIN PULMONARY ARTERY. THE PATIENT REMAINED CLINICALLY STABLE UNDER CLOSE OBSERVATION. SUPPLEMENTAL OXYGEN AT 8L/MIN WAS ADMINISTERED, AND NO DETERIORATION IN THE PATIENT'S OVERALL CONDITION WAS REPORTED. THE INCIDENT DESCRIPTION PROVIDED BY THE CUSTOMER TO THE FRENCH HEALTH AUTHORITY STATED: THE PROFESSIONALS ARE UNABLE TO SPECIFY THE USAGE ERROR THAT LED TO THE INCIDENT, AT A TIME WHEN THEIR WORKLOADS ARE PARTICULARLY HEAVY.