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

Model Number	NU00748R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A site visit to the facility who reported this event was conducted by our firm.Roi cps, llc kits were observed from receiving through handling, storage, and use of the kits at the user facility with facility staff present.The conclusions drawn and storage and handling recommendations to the facility are attached to this report for reference.
Event or Problem Description
Tears and small holes noted in vented bag.

• Brand Name: REGARD
• Common Device Name: CRANIOTOMY 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: 18865976
• Report Number: 3014527682-2024-00011
• Device Sequence Number: 8240041
• Product Code: OJG
• UDI-Device Identifier: 10194717114307
• UDI-Public: 10194717114307
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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
• Device Expiration Date: 08/02/2024
• Device Model Number: NU00748R
• Device Catalogue Number: 880318018
• Device Lot Number: 98976
• 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: 02/29/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2023
• 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