MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-EYE BANK DONOR LIFE

Catalog Number	DYNJ908648B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the ophthalmic eye wash solution was leaking in the pre made kits, the papers were obviously stained, the eye wash bottles were stained and had a lower volume, and the cases have no shipping damage.Medline reviewed finished good production records, finished good pack build, trending, current stock, and a physical sample of four packs; the stock check found no defects and the production record had no line-down situations, runs without approvals, deviations, or non-conformance reports that might have had an impact on this issue.Sample evaluation found visible water damage on multiple components, bottles not full of the eye wash solution, liquid damage to the outside of the pack, and some eye washes had a loose heat seal on the top; this confirmed the issue.Medline determined this to be a vendor-product issue, noting the item was received pre-sealed from the component supplier and there is no additional manipulation during the manufacturing process, and provided the complaint to the vendor for further evaluation while supplier quality 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.
Event or Problem Description
It was reported that "we have had a recent issue with the ophthalmic eye wash solution leaking in the pre made kits.Seems to be happening prior to us receiving as nothing has been wet but the papers are obviously stained, the eye wash bottles are stained and had a lower volume.".

• Brand Name: MEDLINE
• Common Device Name: DBD-EYE BANK DONOR LIFE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50791911
• Report Number: 1417592-2026-42592
• Device Sequence Number: 9524872
• Product Code: OJK
• UDI-Device Identifier: 40195327269778
• UDI-Public: 40195327269778
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/15/2026

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: DYNJ908648B
• Device Lot Number: 23KBV787
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2024
• 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: 05/02/2024
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown