MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ENDO KIT

Catalog Number	DYKE1412
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "multiple endo kits have been dlvrd and wet inside the packaging" and the "issue continues to happen on multiple lot numbers.".
Additional Manufacturer Narrative
The account reported finding bedside kit leaked after reporting that multiple endo kits were wet inside the packaging.A photo was received for investigation, the dhr was reviewed, the bill of materials was reviewed, and trending was reviewed.Per evaluation of the photo received, the photo shows the back of the kit and the blue tote used for the kit does appear to be wet confirming the reported issue; however, no other components from the kit are shown in the photo and bedside component item 59600 bedside kit 500ml is not shown.Due to this, medline was unable to confirm the root cause for the reported issue, and the information reviewed does not indicate that a death or serious injury would be likely to occur if the product problem/issue were to recur.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: ENDO KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916209
• Report Number: 1417592-2026-52111
• Device Sequence Number: 5369789
• Product Code: PPB
• UDI-Device Identifier: 10889942460557
• UDI-Public: 10889942460557
• 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): 09/28/2026

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: DYKE1412
• Device Lot Number: 25EMH772
• Was Device Available for Evaluation?: No
• 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: 07/03/2025
• Initial Report FDA Received Date: 09/28/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown