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

Model Number	85937286
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injector, serial number (b)(6), was completed on october 23 2025 which confirmed that the injector was operating within bayer specifications.There was no evidence of equipment malfunction.The stellant disposable set that was in use during the procedure was discarded by the site and unavailable for evaluation.The customer was unable to provide the lot number of the disposables used during the incident; therefore, testing of retained samples was not possible.The offer of additional clinical applications training has been made to the customer and was declined.The medrad® stellant ct injection system operation manual cautions the user as follows: warning: vessel hazard - serious patient injury may result.Follow institutional extravasation minimizing techniques.A small volume test injection may be utilized to confirm venous access.It is recommended that the operator stay by the patient's side at the beginning of the injection and to instruct the patient to communicate immediately any pain or change in feeling during the injection.Check for extravasation of contrast or saline during injection.If an extravasation is detected, stop the injection and refer to respective facility polity regarding treatment.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 of the abdomen while connected to a medrad® stellant ct injection system (sn (b)(6)).During the examination, the technologist noted that there was no contrast on the images displayed.The patient was evaluated and found that approximately 100ml of contrast had extravasated at the left antecubital injection site.A cold compress was applied to the affected limb, and the patient was referred to a plastic surgeon for consultation.The patient was reported to have recovered after the consultation; however, no further information was provided.

• 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: 23696916
• Report Number: 2520313-2025-00030
• Device Sequence Number: 16024380
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860(11)190903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/02/2025

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: 85937286
• 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: 11/13/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2019
• 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: 47 YR
• Patient Sex: Male