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

Model Number	CDEX31D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sterility issue: during case set up the sterile extremity pack was opened.The clear cover was torn open at which point a hair was seen on the inside of the clear package on the outside of the blue table cover.Pack removed from use and new pack used.

• 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: 8577286
• Report Number: 8577286
• Device Sequence Number: 11195394
• Product Code: LRO
• UDI-Device Identifier: 00191072046109
• UDI-Public: (01)00191072046109(17)200225(10)944191
• 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): 04/17/2019
• Report Date (Section F): 04/17/2019

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: Health Professional
• Device Model Number: CDEX31D
• Device Lot Number: 944191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/17/2019