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

Model Number NU00748R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

Event Type  malfunction  

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 Description

Tears and small holes noted in vented bag.

• Brand Name: REGARD
• Type of Device: 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
• MDR Text Key: 337218968
• Report Number: 3014527682-2024-00011
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10194717114307
• UDI-Public: 10194717114307
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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 Model Number: NU00748R
• Device Catalogue Number: 880318018
• Device Lot Number: 98976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1