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	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer medical care was notified of an extravasation that occurred during an enhanced ct scan while a patient was connected to a medrad® stellant ct injection system, serial number (b)(6).During the injection, the patient complained of pain, swelling and tightness in their arm.The customer reported that approximately 30ml of saline and contrast had extravasated at the patient's left antecubital injection site to which a cold compress was applied.In addition, the attending physician prescribed the application of magnesium sulphate and dexamethasone to the injection site.The patient is reported to be doing well with no other issues reported.
Additional Manufacturer Narrative
The offer of a system service check of the medrad® stellant ct injection system, serial number (b)(6), as well as additional clinical applications training, was declined by the customer.Communication from the customer was that their facility performs a large number of chemoradiotherapy procedures and the risk of extravasation for those patients is high as compared to typical patients.The customer also provided that the physicians of the department are very skilled with the injector and continue to use the medrad® stellant ct injection system after the reported event with no further issues reported.In the event that additional information is obtained, a follow-up report will be submitted.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: 22105193
• Report Number: 2520313-2025-00011
• Device Sequence Number: 15488860
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860(11)200213
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/21/2025

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: 04/25/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2020
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 52 KG