MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. ACS; GENERAL SURGERY TRAY

Model Number	CDEX31D
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While opening pack for the case the scrub person opened one side of the wrap and found a hair on the inside of the drape.The pack was removed from use and a new pack was obtained.This occurred prior to the patient entering the room.

• Brand Name: ACS
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 904 bethel circle; waunakee WI 53597
• MDR Report Key: 8568613
• Report Number: 8568613
• Device Sequence Number: 1666540
• Product Code: LRO
• UDI-Device Identifier: 00191072046109
• UDI-Public: (01)00191072046109(17)200110(10)990191
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/11/2019
• Report Date (Section F): 04/11/2019

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: No Information
• Device Model Number: CDEX31D
• Device Lot Number: 990191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2019
• 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: 04/11/2019