MAUDE Adverse Event Report: ROI CPS, LLC REGARD; T AND A - ROGERS

Model Number	880313005
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Roi cps, llc became aware, through an internal finding, that the kit contained in this report was built with a sterile urethral red rubber catheter 12fr, but the labeling on the custom procedure kit does not include the caution statement, caution: this product contains natural rubber latex which may cause allergic reactions." the urethral red rubber catheter 12fr is a component within the custom procedure kit and is packaged in the original manufacturer package (tyvec pouch) which includes the caution statement on the product label, but the custom procedure kit labeling is considered mislabeled as a result of the omission of the caution statement.

• Brand Name: REGARD
• Common Device Name: T AND A - ROGERS
• 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: 12909963
• Report Number: 3014527682-2021-00023
• Device Sequence Number: 19954363
• Product Code: OGR
• UDI-Device Identifier: 10194717112730
• UDI-Public: 10194717112730
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Relabeling
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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
• Device Expiration Date: 05/08/2023
• Device Model Number: 880313005
• Device Catalogue Number: 880313005
• Device Lot Number: 89378
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/01/2021
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown