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

Catalog Number	DYNJ85791
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 pack was visibly wet throught the wrapper.Sterility was compromised.
Additional Manufacturer Narrative
The customer reported a quality issue: 1 pack was visibly wet throught the wrapper and sterility was compromised.A sample pack was received and reviewed; the back table cover that wrapped the pack was observed to be wet, the pack was opened and the components and subassemblies within were also wet, and component 52011 - saline str 100ml f/irrig had no longer any more liquid within.The reported issue was confirmed.Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process of component 52011 - saline str 100ml f/irrig (seal) that had leaked within the pack; the vendor determined the defect to be from a manufacturing error, and the division will continue to monitor this issue for trending.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: EYE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50721331
• Report Number: 1417592-2026-36440
• Device Sequence Number: 8862414
• Product Code: OJK
• UDI-Device Identifier: 40195327552368
• UDI-Public: 40195327552368
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/06/2026

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: DYNJ85791
• Device Lot Number: 24EBA811
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2024
• 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: 06/20/2024
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (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