MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; EAR, NOSE, AND THROAT SURGICAL TRAY

Model Number	DYNJ33656F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon opening surgical pack "[redacted] head & neck pack", the cst [certified surgical technologist] noticed a brown foreign object in the stack of raytecs "4x4 xray gauze".Cst identified object as potentially unsterile, and pack contaminated.Cst removed the pack from or as well as all opened items, then used a new pack and supplies.Patient was not in the room at time of opening contaminated pack.After new pack and items were opened, case completed without issue.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: EAR, NOSE, AND THROAT SURGICAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 23003783
• Report Number: 23003783
• Device Sequence Number: 9468706
• Product Code: OGR
• UDI-Device Identifier: 10198459135385
• UDI-Public: (01)10198459135385
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025
• Report Date (Section F): 08/26/2025

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: Other
• Device Model Number: DYNJ33656F
• Device Catalogue Number: DYNJ33656F
• Device Lot Number: (10)25DME170
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2025
• 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: 08/26/2025