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

Model Number	9575
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During set up and opening for a surgical case in the operating room, a scrub tech identified a problem with manufacturing packaging of surgical gowns.The inner sterile dust cover around the gown had been sealed in the outer packaging wrap adhesive edge.

• Brand Name: CONVERTORS
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9859708
• Report Number: 9859708
• Device Sequence Number: 14412038
• Product Code: FYA
• UDI-Device Identifier: 10885380153525
• UDI-Public: (01)10885380153525
• 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): 03/03/2020
• Report Date (Section F): 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: No Information
• Device Model Number: 9575
• Device Catalogue Number: 9575
• Device Lot Number: 19JCQ009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2020
• 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: 03/03/2020