MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BILLINGS CLINIC SC T&A PACK; EAR, NOSE, AND THROAT SURGICAL TRAY

Model Number	DYNJ33657B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Sc t&a pack made by medline is supposed to contain 10-4x4 gauze pads.The pack came sealed with only 6-4x4 gauze pads.The pack was opened in the or for the upcoming case.A count of 6-4x4 gauze pads were found instead of the expected 10.The room and patient were double checked just in case they fell while opening the pack.The count of 6 was correct.

• Brand Name: BILLINGS CLINIC SC T&A PACK
• Common Device Name: EAR, NOSE, AND THROAT SURGICAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 10294792
• Report Number: 10294792
• Device Sequence Number: 19488832
• Product Code: OGR
• UDI-Device Identifier: 10889942576081
• UDI-Public: 10889942576081
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020
• Report Date (Section F): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DYNJ33657B
• Device Catalogue Number: DYNJ33657B
• Device Lot Number: 20AMC323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/16/2020