MAUDE Adverse Event Report: ROI CPS, LLC REGARD; CABG A&B

Model Number	CV00361P
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Holes discovered in vented bags of roi cps, llc custom procedure kit 800208016 lots 86469p and 78330p.Event date is unknown.Customer believed it was internal mishandling of the packs that caused the damage.No harm to patient, no case delay and new packs were pulled from inventory.Reporting due to the breach in the sterile pouch.

• Brand Name: REGARD
• Common Device Name: CABG A&B
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• MDR Report Key: 12063720
• Report Number: 3014527682-2021-00009
• Device Sequence Number: 11717453
• Product Code: OEZ
• UDI-Device Identifier: 10194717107255
• UDI-Public: 10194717107255
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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 Model Number: CV00361P
• Device Catalogue Number: 800208016
• Device Lot Number: 86469P, 78330P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1