MAUDE Adverse Event Report: AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 3 HALYARD; GENERAL SURGERY TRAY

Model Number	BMHT011-03_0002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reporting quality issue of product that could lead to potential harm if pack was used during an emergency situation that did not allow time to perform pre-procedure counting: while setting up for a procedure and counting, it was discovered that there were 6 laps in a pack vs the correct amount of 5.

• Brand Name: HALYARD
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 3; 9000 westmont dr.; stonehouse commerce park; toano VA 23168
• MDR Report Key: 20395915
• Report Number: 20395915
• Device Sequence Number: 20842550
• Product Code: LRO
• UDI-Device Identifier: 10809160402771
• UDI-Public: (01)10809160402771(17)270507(10)1593874
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/03/2024
• Report Date (Section F): 07/03/2024

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
• Device Model Number: BMHT011-03_0002
• Device Catalogue Number: BMHT011-03
• Device Lot Number: 1593874
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/03/2024