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

Catalog Number	SNAPSECURE3W
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "snapsecure latch and hinge failures"; "top plastic part is snapping off, some not clamping at all, teeth notch failing.".
Additional Manufacturer Narrative
The customer reported snapsecure latch and hinge failures, including that the top plastic part is snapping off, some not clamping at all, and teeth notch failing; the customer reported no patient harm and no medical intervention, but a new cathgrip was used in its place and securement was replaced.After further review, it was determined that they were likely referring to the 3-way versions snapsecure3w, and a sample assessment and quality investigation was completed.The defect was documented as unconfirmed defect with cause code text "sample required to determine cause," and no root cause was identified.These issues have been addressed with the account, medline urology qa will continue to monitor this issue, and no further action is needed 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 3-WAY FOLEY DEVICE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946719
• Report Number: 1417592-2026-54322
• Device Sequence Number: 18525201
• Product Code: EJY
• UDI-Device Identifier: 20193489102717
• UDI-Public: 20193489102717
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: SNAPSECURE3W
• 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: 02/20/2024
• 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