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

Catalog Number	DYKE1412
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "mold and leaking.".
Additional Manufacturer Narrative
The account reported finding mold and leaking.A photo was received for investigation; the kit was shown opened, the bedside kit 500ml was shown as well the gauze inside of the kit, and the blue drape appeared to have been wet and dried with black coloring observed on the drape and on the gauze pads.However, no damage was shown to the bedside kit 500ml and no water or leakage from the component was shown; the reported issue could not be confirmed without a physical sample.It is unclear what caused the reported issues, and whether the damage to the kit occurred prior to the kit being received or if it happened during transit; therefore, the root cause and responsibility are unable to be confirmed without a physical sample.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
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50896633
• Report Number: 1417592-2026-50738
• Device Sequence Number: 10706165
• 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): 09/24/2026

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: DYKE1412
• 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: 06/13/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown