MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SNAPSECURE 3-WAY FOLEY DEVICE

Catalog Number	SNAPSECURE3W
Medical Device Problem Codes	Failure to Align (2522); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device ¿un-snaps and won¿t re-snap.¿.
Additional Manufacturer Narrative
The complaint reported that the snapsecure product was ¿un-snaps and won¿t re-snap¿; the original reporter also stated the customer was ¿having issues with it un snapping causing the foley to move around¿ and that ¿once it un-snaps, the product won¿t re-snap,¿ with no patient harmed and no medical intervention necessary.Medline quality received 1 ea of the reported product in unpackaged, used condition; visual assessment revealed that the hooks were bent backwards and misaligned, and functional testing was conducted by attempting to close the securement device.The reported issue was verified by visual assessment and functional testing because the snapsecure was not able to close due to the misalignment of the hooks and latch.Based on the provided sample and the description of the issue, the likely root cause is a product defect affecting the alignment of the hooks and latch of the device; the manufacturing facility is aware of this issue and improvements to the design of the product are currently in process to prevent hook arms bending/breaking, improve latching engagement, and reduce misalignment.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 3-WAY FOLEY DEVICE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50946364
• Report Number: 1417592-2026-54234
• Device Sequence Number: 9552071
• Product Code: EYJ
• UDI-Device Identifier: 10193489102710
• UDI-Public: 10193489102710
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/29/2026

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: SNAPSECURE3W
• Device Lot Number: 67024044502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2025
• 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: 01/14/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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