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

Model Number CDEX31D

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2019

Event Type  malfunction  

Event Description

During case set up the asepto in the extremity pack had an unknown substance on it.The pack and all instruments were removed.New set up started.Patient was not in the room.Pack saved.

• Brand Name: ACS
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 7802 e telecom pkwy; tampa FL 33637
• MDR Report Key: 9081665
• MDR Text Key: 158983905
• Report Number: 9081665
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00191072046109
• UDI-Public: (01)00191072046109(17)200608(10)41191
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• 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: 41191
• 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: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 125