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

Model Number	GS00086V
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Hole discovered in vented bag.Pack was removed and replaced with sterile item from supply.
Additional Manufacturer Narrative
A site visit to the facility who reported this event was conducted as part of the investigation.Roi cps, llc kits were observed from receiving through handling, storage, and use of the kits.Observers included roi cps, llc personnel as well as personnel from the user facility.The conclusions drawn from the visit and the recommendations to the facility are attached to this report.
Event or Problem Description
Hole discovered in vented bag.Pack was removed and replaced with sterile item from supply.

• Brand Name: REGARD
• Common Device Name: MAJOR 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: 18746612
• Report Number: 3014527682-2024-00004
• Device Sequence Number: 3740845
• Product Code: LRO
• UDI-Device Identifier: 10194717113829
• UDI-Public: 10194717113829
• 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): 02/21/2024

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: 10/08/2025
• Device Model Number: GS00086V
• Device Catalogue Number: 880086
• Device Lot Number: 98266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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