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

Model Number CDEX31D

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

Event Type  malfunction  

Event 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
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 904 bethel circle; waunakee WI 53597
• MDR Report Key: 8577286
• MDR Text Key: 143976535
• Report Number: 8577286
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00191072046109
• UDI-Public: (01)00191072046109(17)200225(10)944191
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDEX31D
• Device Lot Number: 944191
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1