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

Lot Number 736211

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

Surgeon scrubbed for surgery.When drying hands with disposable blue towel from pack, visible blue, from american contract systems general surgery tray, lint fibers were noted on his arms.Towel and pack contents sheet were kept aside and manager notified.

• Brand Name: ACS
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 4801 west 81st street; bloomington MN 55437
• MDR Report Key: 12727446
• MDR Text Key: 279333156
• Report Number: 12727446
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 736211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1