MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLAT 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	Infiltration into Tissue (1931)
Date of Event	08/25/2022
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 flex injection system.Post injection, the customer reported that approximately 70 ml of contrast extravasated at the patient's left antecubital injection site.The affected extremity was elevated, and ice/warm compresses were applied.The patient was transported by vehicle to the ordering physician's office for further evaluation.Post care instructions were provided, and the patient was reportedly waiting for the swelling and pain to subside.
Additional Manufacturer Narrative
A system service check of the medrad® stellant flex ct injector (sn (b)(4)) was completed on august 29, 2022, which confirmed that the injector was operating within bayer specifications.There was no evidence of equipment malfunction.The stellant disposable set that was in use during the procedure was discarded by the site and unavailable for evaluation.The customer was unable to provide the lot number of the disposables used during the incident; therefore, testing of retained samples was not possible.The offer of additional clinical applications training has been made to the customer and was declined.The site continues to use the medrad® stellant flex ct injection system after the reported event with no further issues reported.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

• Brand Name: STELLAT 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: diane eckert ; 1 bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 15412536
• Report Number: 2520313-2022-00029
• Device Sequence Number: 5894584
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Female