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	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When prepping for a case, scrub tack opened medline head & neck pack and found foreign object (material) inside the ray-tec sponge compromising entire pack.Sponge was saved in biohazard bag and the rest of the pack was disposed of.Patient was not in the room yet.New pack was opened and case prepping continued.

• 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: 21178170
• Report Number: 21178170
• Device Sequence Number: 4286920
• 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): 01/08/2025
• Report Date (Section F): 01/10/2025

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
• Device Model Number: DYNJ33656F
• Device Catalogue Number: DYNJ33656F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• 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: 01/10/2025