MAUDE Adverse Event Report: Terumo Cardiovascular Costa Rica LLC Terumo Cardiovascular Procedure Kit; Cardiovascular Procedure Kit - Convenience Tubing Pack

Model Number	CX-UK695
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction

• Brand Name: Terumo Cardiovascular Procedure Kit
• Common Device Name: Cardiovascular Procedure Kit - Convenience Tubing Pack
• Manufacturer (Section D): Terumo Cardiovascular Costa Rica LLC; 58 calle; cartago, zona franca la lima 30106 ; CS 30106
• Manufacturer (Section G): Same
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; +1(734)663-4145
• MDR Report Key: 50872965
• Report Number: 3017987980-2026-00012
• Device Sequence Number: 9426061
• Product Code: OEZ
• UDI-Device Identifier: 00699753531154
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: CX-UK695
• Device Lot Number: 0000869280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown