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

Model Number	CDLA37E
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sterile laparotomy supply pack contained a contaminate: hair found underneath the stryrofoam tray.Pack & hair retained.Hair 1 3/4" brown.Discovered when tray moved during table set-up.Since sterility of surgical field was in question, field discarded and another sterile field set-up discovered prior to patient exposure; no patient harm.

• 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: 9334723
• Report Number: 9334723
• Device Sequence Number: 11387337
• Product Code: LRO
• UDI-Device Identifier: 00191072073242
• UDI-Public: (01)00191072073242(17)200718(10)801191
• 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): 10/21/2019
• Report Date (Section F): 10/21/2019

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: CDLA37E
• Device Lot Number: 801191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2019
• 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: 10/21/2019