MAUDE Adverse Event Report: ROI CPS, LLC REGARD; ANGIOGRAPHY DRAPE PACK

Model Number	HT00026L
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple packs have black particulate on drapes, back table cover and in bowl.Dates of events were not provided by the customer.

• Brand Name: REGARD
• Common Device Name: ANGIOGRAPHY DRAPE PACK
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• MDR Report Key: 9780134
• Report Number: 3014527682-2020-00002
• Device Sequence Number: 2877942
• Product Code: OEQ
• UDI-Device Identifier: 10194717102632
• UDI-Public: 10194717102632
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: 11/09/2020
• Device Model Number: HT00026L
• Device Catalogue Number: 880023012
• Device Lot Number: 73652L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1