MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	60726807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The offer of an injector check by bayer service has been declined by the customer.The medrad® stellant disposable set that was in use during the procedure was discarded by the site; therefore, they are not available for evaluation.The customer was unable to provide the lot number of the disposables; therefore, testing of retained samples was not possible.Additional applications training was offered; however, the customer declined.The site continues to use the stellant ct injection system after the reported event with no further issues reported.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.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
The customer reported the following: a patient was undergoing an enhanced ct scan while connected to a medrad® stellant ct injection system (sn (b)(6)).Following the injection, an undisclosed amount of air was visualized on the subsequent images.The patient was placed on high flow oxygen via a non-rebreather facemask and was placed on their left side in trendelenburg position.The patient was subsequently admitted to the hospital for observation and was discharged the following day without further issue.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: lois miller ; 1 bayer drive; indianola, PA 15051 ; 7249406847
• MDR Report Key: 24766355
• Report Number: 2520313-2026-00011
• Device Sequence Number: 13336841
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943(11)161222
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60726807
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SDS MP2 AND SSS-SPD-250 LOT NOS. UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown