MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SNAPSECURE FOLEY DEVICE

Catalog Number	SNAPSECURE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the lockdown pops off".
Additional Manufacturer Narrative
The customer reported snapsecure detachment and stated, "the lockdown pops off"; the complaint transcript indicated the issue did not occur during use and no injury occurred.Medline quality received a photo of the reported product, and assessment of the provided photograph revealed that the snapsecure detached from the base and adhesive pad.The reported issue was confirmed with the received photo, but a vendor investigation could not be completed, as no response was received.The root cause could not be identified at this time, there are currently no known trends for this product, and no additional action is necessary at this time.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: SNAPSECURE FOLEY DEVICE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946387
• Report Number: 1417592-2026-54240
• Device Sequence Number: 21220498
• Product Code: EYJ
• UDI-Device Identifier: 10193489010466
• UDI-Public: 10193489010466
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: SNAPSECURE
• Device Lot Number: 67025054503
• 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: 11/20/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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