MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD® STELLANT FLEX SYRINGE KIT; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	FLEXS-150-QFT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The iv contrast could not be administered through the proper tubing because the tubing that connects to the syringe was leaking.The injection was stopped and the tubing was readjusted but did not correct the issue.The contrast was initially leaking but as the pressure built it came out all over the technologist.

• Brand Name: MEDRAD® STELLANT FLEX SYRINGE KIT
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 625 alpha dr; pittsburgh PA 15238
• MDR Report Key: 24469388
• Report Number: 24469388
• Device Sequence Number: 10277495
• Product Code: DXT
• UDI-Device Identifier: 00616258022895
• UDI-Public: (01)00616258022895
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026
• Report Date (Section F): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FLEXS-150-QFT
• Device Catalogue Number: FLEXS-150-QFT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/20/2026