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	Extravasation (1842)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (serial number (b)(6)) was completed on (b)(6) 2026 and confirmed that the injector was operating within bayer specifications.The medrad® stellant disposable set used during the procedure was discarded by the site and was therefore unavailable for evaluation.The customer was unable to provide the lot number of the disposables in use at the time of the incident; consequently, testing of retained samples was not possible.The customer also declined the offer of additional clinical applications training.The site continues to use the medrad® stellant ct injection system after the reported event, with no further issues reported.A review of the device history record (dhr) confirmed that the medrad® stellant injector system was manufactured in accordance with established requirements, with no identified deviations, nonconformances, failures, or quality-related issues.The medrad® stellant ct injection system operation manual cautions the user as follows: 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 policy 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
Bayer medical care was notified of the following event: a 47-year-old patient underwent a ct examination of the abdomen and pelvis while connected to a medrad® stellant ct injection system (serial number (b)(6)).A 22-gauge intravenous catheter was placed in the patient's left wrist, which was noted to be a difficult intravenous insertion.Post injection, when no contrast was observed in the acquired ct images, the customer reported that approximately 100 ml of fluid extravasated into the patient's left wrist area.Consequently, the patient developed compartment syndrome and later required a surgical fasciotomy.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola 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: 24579027
• Report Number: 2520313-2026-00009
• Device Sequence Number: 9233201
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943(11)161026
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 03/12/2026

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: 03/04/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Unknown