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	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a 17-year-old male patient in the emergency department underwent a contrast-enhanced ct scan.The procedure was performed using a medrad® stellant flex ct injection system (serial number (b)(6)).Following completion of the contrast injection, an undetermined amount of air was visualized on the acquired ct images.Oxygen was administered and the patient was subsequently admitted for observation.The current status of the patient is unknown.
Additional Manufacturer Narrative
A system service check of the medrad® stellant flex ct injector (serial number (b)(6)) was performed on (b)(6) 2026.The service evaluation confirmed that the injector was functioning within bayer specifications at the time of assessment.The customer reported that the disposables used during the incident were discarded at the site and were therefore not available for analysis.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 has been accepted by the customer and will be scheduled.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.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 24277546
• Report Number: 2520313-2026-00005
• Device Sequence Number: 8365471
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219(11)241209
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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
• Device Model Number: 85577026
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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: 17 YR
• Patient Sex: Male
• Patient Weight: 54 KG