MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; ORTHOPEDIC TRAY

Model Number	SOP56TK80H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While bringing the draped mayo stand into the sterile field, it was noticed that there were large holes in the drape along the side of the mayo stand.The surgeon was present and consulted and it was decided to remove the outer gloves of the scrub tech and cover the holes and any areas that she may have touched with sterile ioban.The inner wrapping of the pack which the mayo stand cover came in was saved.

• Brand Name: CARDINAL HEALTH
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9864863
• Report Number: 9864863
• Device Sequence Number: 14172541
• Product Code: OJH
• UDI-Device Identifier: 10888439420388
• UDI-Public: (01)10888439420388
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020
• Report Date (Section F): 02/12/2020

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: No Information
• Device Model Number: SOP56TK80H
• Device Catalogue Number: SOP56TK80H
• Device Lot Number: 340859
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 111
• Date Report Sent to FDA: 02/12/2020