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	Extravasation (1842)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check report of the medrad® stellant flex ct injection system, serial number (b)(6), completed may 22, 2025, verified it was operating within bayer specification.The medrad® stellant flex disposable syringe kit (flexd-150-spk), lot number 8665883, in use during the procedure, was discarded by the site; therefore, it is not available for evaluation.Bayer product analysis tested retained samples of the flexd-150-spk, batch number 8665883, and concluded that the retained disposables performed to specification with no problems observed.An offer for additional applications training was accepted by the site and performed (b)(6) 2025.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 informed that a 44-year-old female suffered an extravasation while connected to a medrad® stellant flex ct injection system (sn (b)(6).The customer reported that approximately 16 ml of fluid was extravasated in the patient's right antecubital.Following the event, a warm compress was applied to the infiltration site, a radiologist assessed the patient iv site, and an x-ray was performed to document the extent of the extravasation.The patient is reported as doing well.

• 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: 22143527
• Report Number: 2520313-2025-00012
• Device Sequence Number: 15488814
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219(11)190831
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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: 85577026
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLEXD-150-SPK, BATCH NUMBER 8665883
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female