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	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the whole case of 9 were leaking" and "the bedside cleaning kit has rupture inside the bag and has soiled the rest of the individual packaged kit.".
Additional Manufacturer Narrative
The account reported finding bedside cleaning kit leaked, and the customer reported that all 9pk (9/cs) are now defective.One photo was received from the account to aid the investigation; a physical sample was not available, finished good production records were reviewed, and the bill of materials (bom) and packaging instructions were reviewed.Based on review of the one photo provided from the account, medline confirmed moisture found within one pack; none of the components are visible in the photo.The root cause of the reported issue could not be determined, 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: ENDO KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50714591
• Report Number: 1417592-2026-35728
• Device Sequence Number: 10640973
• 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): 09/05/2026

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: 25HME679
• Was Device Available for Evaluation?: Yes
• 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: 10/28/2025
• Initial Report FDA Received Date: 09/10/2026
• 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