MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HEAD NECK

Catalog Number	DYNJ907685D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterile water cracked / leaking.
Additional Manufacturer Narrative
The customer reported that the bottle of water was already opened when she was opening her pack, and the account reported finding sterile water leaked.Four photos were received for investigation; the photos were up-close views of the sterile water bottle and the identifying label, finished good production records and finished good pack build were reviewed, and the vendor reviewed the provided photo, their non-conformance system database, and retained samples.Medline observed the bottle, contained in a bag, with water leaked all around it, confirming the reported issue; the vendor was unable to determine the source of the leakage as the bottle appeared intact, found no related or similar discrepancies during production, and no leakage was observed in retained samples.Further analysis suggests that the damage most likely occurred at some point during production, transit, or storage; however, with the information provided, the exact stage at which the damage occurred could not be determined, 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: HEAD NECK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50766642
• Report Number: 1417592-2026-40281
• Device Sequence Number: 13126615
• Product Code: OGR
• UDI-Device Identifier: 10198459136931
• UDI-Public: 10198459136931
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/14/2026

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: DYNJ907685D
• Device Lot Number: 25EBC140
• 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: 07/31/2025
• Initial Report FDA Received Date: 09/15/2026
• 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