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	02/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The dust cover was taken off of a sterile gown to open it onto the operative field and noticed that the blue wrap was not fully covering the gown, therefore making the gown contaminated.The gown with identifying paper work to the manager.This is not the first time this has happened.The gowns are coming from the manufacturer this way.

• Brand Name: CONVERTORS
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8357205
• Report Number: 8357205
• Device Sequence Number: 1954489
• Product Code: FYA
• UDI-Device Identifier: 10885380153525
• UDI-Public: (01)10885380153525(17)231001(10)18KBJ027
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/19/2019
• Report Date (Section F): 02/19/2019

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: Other
• Device Model Number: 9575
• Device Catalogue Number: 9575
• Device Lot Number: 18KBJ027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/19/2019