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

Model Number	CDEX31D
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Sterility issue, hair in sterile pack: cmc extremity pack opened on back table.Removed self-contained sterile splash basin pack to ring stand.Upon opening the sterile wrap enclosing the splash basin, saw a hair against the sidewall of the inner basin.Splash and contents not used; additional sterile supplies obtained.

• Brand Name: ACS
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 7300 w detroit st; chandler AZ 85226
• MDR Report Key: 9888212
• Report Number: 9888212
• Device Sequence Number: 2248193
• Product Code: LRO
• UDI-Device Identifier: 00191072046109
• UDI-Public: (01)00191072046109(17)210214(10)955201
• 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): 03/23/2020
• Report Date (Section F): 03/23/2020

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: CDEX31D
• Device Lot Number: 955201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2020
• 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: 03/23/2020