MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	89-5525
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A percutaneous tray pack was opened.Inside the pack, there were 7 small sponges when there should have only been 5.The small sponges were removed from the field and placed in a bag with the packaging label for the pack and given to the charge nurse.

• Brand Name: DEROYAL
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 7880956
• Report Number: 7880956
• Device Sequence Number: 1837421
• Product Code: OEQ
• UDI-Device Identifier: 00749756640473
• UDI-Public: (01)00749756640473
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/11/2018
• Report Date (Section F): 09/11/2018

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 Model Number: 89-5525
• Device Lot Number: 47941027
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/11/2018