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 Codes	Extravasation (1842); Infiltration into Tissue (1931)
Date of Event	09/25/2023
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 (sn (b)(6)).An estimated 56 ml of contrast extravasated at the injection site.A cold compress was applied to the affected extremity and an ultrasound examination was performed the following day which confirmed that the issue had resolved.
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system, serial number (b)(6), was declined by the customer.The customer discarded the suspect disposables at the time of the incident; however, they were able to provide a lot number for the disposable kit that was in use.Bayer product analysis tested a retained sample from disposable sjs-pt-j kit, lot number 8621072.Functional testing concluded that the retained disposables performed to specification with no problems observed.An offer for additional applications training has been made and declined by the site.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Additional Manufacturer Narrative
Udi related data quality updates only.Correction: for udi data discrepancy/mismatch on previously submitted mdr and to ensure the device identification data is in alignment with gudid.

• 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: 17986637
• Report Number: 2520313-2023-00026
• Device Sequence Number: 8167059
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860(11)220519
• 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,Followup
• Report Date (Section B): 09/23/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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: SJS-PT-J - LOT 8621072
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female