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

Model Number	HT00051Q
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Hole in vented bag.Discovered during set up.No delay to case.No harm to the patient.

• Brand Name: REGARD
• Common Device Name: CARDIAC CATH PACK
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• MDR Report Key: 12240725
• Report Number: 3014527682-2021-00015
• Device Sequence Number: 19628505
• Product Code: OES
• UDI-Device Identifier: 10194717110002
• UDI-Public: 10194717110002
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/28/2021

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: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: HT00051Q
• Device Catalogue Number: 880051017
• Device Lot Number: 88209Q
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1