MAUDE Adverse Event Report: ROI CPS, LLC REGARD; CABG PACK PART B

Model Number	CV01061
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was a slit in the vented bag of the convenience kit that appeared to be from a box cutter leaving the pack non-sterile.The slit was identified by hospital staff prior to the pack being stored in sterile supply and was discarded.The kit was not returned for investigation into the incident.The source of the cut is unknown.There was no patient contact.

• Brand Name: REGARD
• Common Device Name: CABG PACK PART B
• 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: 17604458
• Report Number: 3014527682-2023-00009
• Device Sequence Number: 6138945
• Product Code: OEZ
• UDI-Device Identifier: 10194717116981
• UDI-Public: 10194717116981
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 08/23/2023

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: 12/26/2024
• Device Model Number: CV01061
• Device Catalogue Number: 800250000
• Device Lot Number: 96156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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