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

Model Number	85577026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
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; therefore, testing of retained samples was not possible.The offer of additional clinical applications training was declined by the customer.The medrad® stellant flex 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
Bayer medical care inc.Was informed that a 73-year-old male undergoing a ct scan experienced an alleged air injection while connected to a medrad® stellant flex injection system (sn (b)(6)).Following the injection, the customer had reported seeing air bubbles on the displayed images within the right ventricle, the right sub-clavicular region, and in the superior vena cava.The patient was admitted to the hospital and received follow-up imaging which showed that the air had resolved.The patient is reported as doing well.

• 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: jason johnson ; 1 bayer drive; indianola, PA 15051 ; 4124063016
• MDR Report Key: 22902134
• Report Number: 2520313-2025-00021
• Device Sequence Number: 8851288
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219(11)211130
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192370
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: 85577026
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male