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	Infiltration into Tissue (1931)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer service visited the customer site and performed a system checkout.The injector system was found to perform to specifications.The disposables and /or lot numbers of the disposables used in the reported incident are unavailable at this time.If more information becomes available, an additional investigation will be performed, and 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.
Event or Problem Description
The following report was received from a bayer representative: on (b)(6) 2021, the site reported to a bayer representative that a patient had suffered an extravasation a few months ago while connected to a medrad® stellant ct injection.The patient was reported to require surgical intervention post incident.The customer's risk management representative stated that there was no issue identified with the medrad® stellant ct injection system during their internal investigation.In addition, the injector system has been in use daily since the occurrence.Multiple attempts have been made to obtain additional details from the customer without response at this time.

• 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
• MDR Report Key: 11230409
• Report Number: 2520313-2021-00001
• Device Sequence Number: 14404140
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization