MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-HEAD AND NECK/ENT PACK

Catalog Number	DYNJ01962L
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when she received this item it was coverend in a wet substance.".
Additional Manufacturer Narrative
The account reported finding wet substance found on pack.Finished good production records were reviewed, finished good pack build was reviewed, and a sample was received for investigation; the account returned 11 unopened packs, and after visual inspection and opening the packs, no signs of moisture, wet substance, or components that were wet were observed.Based on the received samples, medline was unable to confirm the reported issue.We were unable to confirm the issue reported with the provided sample, and as a result, we could not identify the root cause.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-HEAD AND NECK/ENT PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50524624
• Report Number: 1417592-2026-28497
• Device Sequence Number: 12250036
• Product Code: OGR
• UDI-Device Identifier: 40195327249558
• UDI-Public: 40195327249558
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 08/29/2026

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: DYNJ01962L
• Device Lot Number: 24CMI731
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2024
• 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: 09/11/2024
• Initial Report FDA Received Date: 08/31/2026
• 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