MAUDE Adverse Event Report: ROI CPS, LLC REGARD; CV PACK A&B-OHH

Model Number	CV003320
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Hole in the vented bag that did not appear to go through to the back table cover of the sterile custom surgical kit.The hole in the vented bag was identified while unboxing the kit out of the shipping container.The pack was discarded prior to use.

• Brand Name: REGARD
• Common Device Name: CV PACK A&B-OHH
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• MDR Report Key: 9506480
• Report Number: 3014527682-2019-00004
• Device Sequence Number: 19432067
• Product Code: OEZ
• UDI-Device Identifier: 20194717104206
• UDI-Public: 20194717104206
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: CV003320
• Device Catalogue Number: 880237015
• Device Lot Number: 72732ORW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1