MAUDE Adverse Event Report: ROI CPS, LLC REGARD; CV MINOR KIT

Model Number	CV00979A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Roi cps, llc became aware, after receiving an inquiry from an end user facility regarding a non-sterile ultrasound gel 20gm ns being used in a sterile cv minor procedure kit.The non-sterile item is in a foil package that is labeled as non-sterile and cannot be sterilized in the roi cps, llc sterilization cycle due to penetration of eo gas being prevented by the foil packaging.The gel is required to be sterile for use in the cv minor procedure kit.

• Brand Name: REGARD
• Common Device Name: CV MINOR KIT
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 14477747
• Report Number: 3014527682-2022-00006
• Device Sequence Number: 17341796
• Product Code: OEZ
• UDI-Device Identifier: 10194717101949
• UDI-Public: 10194717101949
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

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 Expiration Date: 02/08/2024
• Device Model Number: CV00979A
• Device Catalogue Number: 800774001
• Device Lot Number: 91423
• 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: 05/19/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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