MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-BASIC OPHTHALMIC PACK

Catalog Number	DYNJ07780R
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pack was open at the opening of the bag when they took it out of the case.
Additional Manufacturer Narrative
The account reported finding open seal, and the complaint transcript states the pack was open at the opening of the bag when they took it out of the case.A photo and a sample were received, one pack was evaluated, finished good production records and finished good pack build were reviewed, and trending was reviewed.The reported problem was confirmed: the edge seam of the pouch on the tyvek end was open along the top, middle of the bag, and a white line running along the edge seam indicated that the pouch did go through a sealing machine and was closed at some point in time.Medline receives this item pre-sealed from the component supplier, and the root cause was confirmed as related to an error in the component manufacturing process; the complaint was provided to the vendor for further evaluation and 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.

• Brand Name: MEDLINE
• Common Device Name: DBD-BASIC OPHTHALMIC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: cyrus johnson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50821471
• Report Number: 1417592-2026-45045
• Device Sequence Number: 21502079
• Product Code: OJK
• UDI-Device Identifier: 40195327466719
• UDI-Public: 40195327466719
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/18/2026

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: DYNJ07780R
• Device Lot Number: 23HBI184
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2023
• 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: 11/01/2023
• Initial Report FDA Received Date: 09/18/2026
• 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