MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MINOR CORE PACK-LF

Catalog Number	DYNJ0773431O
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "broken light handle cover".
Additional Manufacturer Narrative
The customer reported finding broken light handle cover; the issue did not occur during use and no injury occurred.A sample was received for our investigation, one pack was provided partially opened without its breather pouch, the interior components were noted to not be in their original locations, the tray was observed to be damaged as it was bent or dented on certain spots, and the rigid light handle cover was located.Per review of the sample provided the light handle cover was confirmed to be bent and misshapen.Given this the item was either damaged prior to placement in the pack and was not noted during assembly or the item became damaged due to rough handling of the pack; with the information provided it could not be determined at what point this occurred, and the division will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-MINOR CORE PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50721237
• Report Number: 1417592-2026-36434
• Device Sequence Number: 10367831
• Product Code: FDE
• UDI-Device Identifier: 10198459052262
• UDI-Public: 10198459052262
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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 Catalogue Number: DYNJ0773431O
• Device Lot Number: 25CBC837
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown