MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; EENT SPLIT PACK

Catalog Number	DYNJ43447D
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one of the tubings inside the pack was not placed properly, and its sticking out the side of the pack, compromising sterility.".
Additional Manufacturer Narrative
The account reported finding assembly issue; the customer stated that the product was received with tubing improperly positioned and protruding from the side of the pack, compromising sterility.No sample or photo was received for investigation; finished good production records and finished good pack build were reviewed, and there were no line down situations, deviations, run-without, or non-conformance reports that might have had an impact on this issue.At this time, the reported defect cannot be confirmed because no physical sample or detailed photographic evidence was provided; the incident cannot be confirmed due to the lack of photographic or physical evidence.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: EENT SPLIT PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856068
• Report Number: 1417592-2026-47812
• Device Sequence Number: 18622711
• Product Code: OGR
• UDI-Device Identifier: 10198459165900
• UDI-Public: 10198459165900
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/22/2026

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: DYNJ43447D
• Device Lot Number: 25GBD396
• Was Device Available for Evaluation?: Yes
• 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: 11/13/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown