MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ENDO PACK JP

Catalog Number	DYKE2038A
Medical Device Problem Code	Powder Leak (4069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "several kits have contained broken solidifier packs, resulting in the contents spilling and covering multiple items inside the kit when we open them.".
Additional Manufacturer Narrative
The complaint reported solidifier leaked and stated that the customer opened pack and powder from solidifier flew in to customers eye; they went to occ health to get eye flush.No sample or photo was received for the investigation; the device history records were reviewed, no non-conformances were noted that could have contributed to the reported issue, the pack build was reviewed, and trending was reviewed.At this time, medline was unable to confirm the reported defect, as no physical sample and no detailed photographic evidence was provided to support the investigation.The cause was documented as sample required to determine cause under unconfirmed defect, 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: DBD-ENDO PACK JP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50888870
• Report Number: 1417592-2026-50430
• Device Sequence Number: 9939478
• Product Code: OFF
• UDI-Device Identifier: 10198459445576
• UDI-Public: 10198459445576
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/24/2026

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: DYKE2038A
• Device Lot Number: 25GBN856
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2026
• 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: 02/11/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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