MAUDE Adverse Event Report: Resource Optimization & Innovation, LLC Regard; CVR BT FLD RST NSKD POLYCT TIE BL L

Model Number	CVRBTTIEL-REG
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction

• Brand Name: Regard
• Common Device Name: CVR BT FLD RST NSKD POLYCT TIE BL L
• Manufacturer (Section D): Resource Optimization & Innovation, LLC; 1100 martin l king jr blvd; ste 1100; nashville TN 37203
• Manufacturer (Section G): Resource Optimization & Innovation, LLC; 1100 martin l king jr blvd; ste 1100; nashville TN 37203
• Manufacturer Contact: kannan suresh kumar ; 1100 martin l king jr blvd; ste 1100; nashville, TN 37203 ; +1(573)578-0433
• MDR Report Key: 50008595
• Report Number: 3004513970-2026-00002
• Device Sequence Number: 12864728
• Product Code: FXP
• UDI-Device Identifier: 00326053119132
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: CVRBTTIEL-REG
• Device Catalogue Number: CVRBTTIEL-REG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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