MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MAJOR SURGERY FMOL LADY OF THE

Catalog Number	DYNJ89561
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had 2 major surgery packs back-to-back that had pieces of black debris in them as well as one of them had a gown with some mold on it.".
Additional Manufacturer Narrative
The customer reported that they had 2 major surgery packs back-to-back that had pieces of black debris in them and one of them had a gown with some mold on it; the issue did not occur during use and no injury occurred.A photo and a sample were received for investigation, seven sample packs and a pack insert were provided, and the seven packs were individually opened with the interior components carefully removed; finished good production records and the finished good pack build were reviewed.Out of all seven packs, two were confirmed to have particles found within the 48oz bowl, one confirmed to be a corrugate particle and the other an unknown black particle; black and cardboard particles were found within the pack while the report of a dirty gown was not confirmed at this time.The original source of the black particles could not be identified, and the cardboard particle was small fragments of material originating from component packaging; the complaint was provided to the vendor for further evaluation 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-MAJOR SURGERY FMOL LADY OF THE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50949686
• Report Number: 1417592-2026-54757
• Device Sequence Number: 10429259
• Product Code: FDE
• UDI-Device Identifier: 10198459278297
• UDI-Public: 10198459278297
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/29/2026

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: DYNJ89561
• Device Lot Number: 25BBQ872
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2025
• 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: 07/25/2025
• Initial Report FDA Received Date: 09/30/2026
• 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