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

Model Number	85631829
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer medical care inc.Was informed that a 62-year-old female undergoing a ct of the chest, abdomen and pelvis had experienced an alleged air injection while connected to a medrad® stellant flex injection system (sn (b)(6)).Following completion of the procedure, a radiologist observed 18 ml of air on the displayed images and requested that the patient be evaluated in the emergency department.While under observation, a follow-up ct scan was performed which showed that the air had resolved.The patient is reported as doing well.
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 used during the procedure; therefore, testing of retained samples was not possible.The offer of additional clinical applications training was accepted by the customer and is being scheduled with the clinical performance center.The medrad® stellant flex 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; 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: 21412262
• Report Number: 2520313-2025-00006
• Device Sequence Number: 20963319
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792(11)180601
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 85631829
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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: 62 YR
• Patient Sex: Female