STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) WAS DECLINED BY THE CUSTOMER. THE STELLANT MULTI-PATIENT KIT (SDS MP2), BATCH NUMBER 8653312, THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. RETAINED SAMPLES HAVE BEEN REQUESTED AND WILL BE EVALUATED ONCE RECEIVED. 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. CORRECTION NOTE: THE INITIAL MDR (2520313-2025-00010) DATED 03/17/2025 WAS SUBMITTED WITH AN INCORRECT SERIAL NUMBER. THE ORIGINAL INFORMATION PROVIDED BY THE CUSTOMER WAS LATER DETERMINED TO BE INCORRECT. THE CORRECT SERIAL NUMBER OF THE INJECTOR SYSTEM IS (B)(6).

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 40-YEAR-OLD MALE HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). THE AMOUNT OF AIR INJECTED IS UNKNOWN. FOLLOWING THE EVENT, THE PATIENT WAS TRANSFERRED TO A HYPERBARIC CHAMBER FOR FURTHER CARE AND TREATMENT AND IS REPORTED AS DOING WELL.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) WAS DECLINED BY THE CUSTOMER. THE STELLANT MULTI-PATIENT KIT (SDS MP2), BATCH NUMBER 8653312, THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. BAYER PRODUCT ANALYSIS TESTED RETAINED SAMPLES OF THE SDS MP2, BATCH NUMBER 8653312, AND CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE OFFER OF ADDITIONAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THE MEDRAD® STELLANT 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.

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 40-YEAR-OLD MALE HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). THE AMOUNT OF AIR INJECTED IS UNKNOWN. FOLLOWING THE EVENT, THE PATIENT WAS TRANSFERRED TO A HYPERBARIC CHAMBER FOR FURTHER CARE AND TREATMENT AND IS REPORTED AS DOING WELL.

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A PATIENT HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6). THE AMOUNT OF AIR INJECTED IS UNKNOWN. FOLLOWING THE EVENT, THE PATIENT WAS TRANSFERRED TO A HYPERBARIC CHAMBER FOR FURTHER CARE AND TREATMENT AND IS REPORTED AS DOING WELL.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6) WAS DECLINED BY THE CUSTOMER. 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.