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

Model Number	CDMH06F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Hair found in anterior hip pack.Tables contaminated and all torn down; patient was in the operating room.Small hair was found in opening flaps of unopened suture, #1 ethibond x538, within the pack.

• Brand Name: ACS
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 7802 e telecom pkwy; tampa FL 33637
• MDR Report Key: 8850686
• Report Number: 8850686
• Device Sequence Number: 18903504
• Product Code: LRO
• UDI-Device Identifier: 00191072055149
• UDI-Public: (01)00191072055149(17)200515(10)865191
• 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): 07/02/2019
• Report Date (Section F): 07/02/2019

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: CDMH06F
• Device Lot Number: 865191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 100
• Date Report Sent to FDA: 07/02/2019