MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MAJOR PACK-LF; GENERAL SURGERY TRAY

Model Number	DYNJ04393G
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An extra lap sponge was found in the major pack.

• Brand Name: MAJOR PACK-LF
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 14914397
• Report Number: 14914397
• Device Sequence Number: 6289609
• Product Code: LRO
• UDI-Device Identifier: 10193489624298
• UDI-Public: 10193489624298
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/22/2022
• Report Date (Section F): 06/22/2022

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: DYNJ04393G
• Device Catalogue Number: DYNJ04393G
• Device Lot Number: 21LMA588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2022
• 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: Female
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 06/22/2022