MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CONVERTORS; DRAPE, SURGICAL, EXEMPT

Model Number	8378
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The operating room tech found a dead bug when opening a cardinal health 200 convertors table cover for a total knee arthroplasty.The contaminated table cover was immediately discharged from the or and a new device was opened to continue the original intended procedure.Nothing else was contaminated during the incident.

• Brand Name: CONVERTORS
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 10331830
• Report Number: 10331830
• Device Sequence Number: 17037823
• Product Code: PUI
• UDI-Device Identifier: 10885380118678
• UDI-Public: (01)10885380118678
• 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): 07/22/2020
• Report Date (Section F): 07/22/2020

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: 8378
• Device Catalogue Number: 8378
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2020
• 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: 07/22/2020