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

Model Number	CDMK10J
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sterility issue w/ sterile surgical pack.Hair found on "bandage, esmark 6"x12' lat free" contained within sterile surgical supply pack.Discovered by scrub person while finishing sterile set-up of one-of-three table.Outcome was two of the three sterile set-ups had to be replaced, 5 sterile instrument trays, and sterile supplies contained on two of the three sterile tables.Contamination discovered and contained prior to patient use.

• Brand Name: ACS
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 7802 e telecom pkwy; tampa FL 33637
• MDR Report Key: 8784737
• Report Number: 8784737
• Device Sequence Number: 16625747
• Product Code: LRO
• UDI-Device Identifier: 00191072057679
• UDI-Public: (01)00191072057679(17)200524(10)856191
• 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): 06/18/2019
• Report Date (Section F): 06/18/2019

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: CDMK10J
• Device Lot Number: 856191
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• 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: 06/18/2019