MAUDE Adverse Event Report: BAYER MEDICAL CARE INC STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	85631829
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® stellant flex ct injection system, serial number (b)(6), completed september 12, 2024, verified it was operating within bayer specification.Bayer product analysis received and tested the medrad® stellant flex disposable syringe kit (flexd-150-scs), lot number 8657149, in use during the procedure and concluded that it performed to specification with no problems observed.An offer for additional applications training has been made and has been accepted by the site.Training will be scheduled in the upcoming weeks.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 72-year-old female experienced an extravasation while connected to a medrad® stellant flex ct injection system (sn (b)(6).The customer reported that approximately 150 ml of fluid was extravasated in the patient's right antecubital.Following the event, the affected limb was elevated, a cold compress was applied to the infiltration site, and the patient was admitted for observation.The current status of the patient is unknown.The site continues to use the injector after the reported event with no further issues reported.

• 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: 20407160
• Report Number: 2520313-2024-00019
• Device Sequence Number: 3579862
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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: 85631829
• 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: 09/10/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2015
• 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-SCS, LOT NUMBER 8657149
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female