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

Model Number	DYNJ42843B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was a contaminated basin set from the minor pack, (it had a black substance inside).The patient was not in the or (operating room) yet, so the table was broke down and a new setup was completed.Minor pack gtin: (b)(4).Expires 2026-02-28.Lot 1023jbb958.Manufacturer: medline.

• Brand Name: MINOR PACK-LF
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18463910
• Report Number: 18463910
• Device Sequence Number: 2984025
• Product Code: LRO
• UDI-Device Identifier: 10193489880427
• UDI-Public: (01)10193489880427
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/18/2023
• Report Date (Section F): 12/18/2023

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: DYNJ42843B
• Device Catalogue Number: DYNJ42843B
• Device Lot Number: 1023JBB958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 96 KG
• Patient Race: White
• Date Report Sent to FDA: 12/18/2023