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

Model Number	GS00085AC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A hole was discovered in the back table cover and in the vented bag holding the kit.There was no patient contact and a new pack was pulled from sterile supply.
Additional Manufacturer Narrative
The sample was returned to the manufacturer for evaluation and it was confirmed that the hole reported was in the vented bag and not in the back table cover.
Event or Problem Description
A hole was discovered in the vented bag holding the kit.There was no patient contact and a new pack was pulled from sterile supply.

• Brand Name: REGARD
• Common Device Name: MINOR PACK
• 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: 18302807
• Report Number: 3014527682-2023-00019
• Device Sequence Number: 17876575
• Product Code: LRO
• UDI-Device Identifier: 10194717113836
• UDI-Public: 10194717113836
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: Other
• Device Expiration Date: 09/28/2025
• Device Model Number: GS00085AC
• Device Catalogue Number: 880085029
• Device Lot Number: 98190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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