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

Catalog Number	SNAPSECURE3W
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "foley securement device broken upon removal from package and did not click closed.".
Additional Manufacturer Narrative
The reported product problem/issue was broken upon removal from package, and the foley securement device did not click closed.Medline quality received 1 ea of the reported product in unpackaged, used condition; visual assessment revealed that one of the hooks was shorter than the other, and functional testing was conducted by closing the securement device.The reported issue of the snapsecure not closing was verified, and the device was not able to close due to the hooks not latching.Based on the provided sample and the description of the issue, the likely root cause is a manufacturing defect resulting in malformed hooks; based on the findings of the quality investigation, no change has been made to the regulatory reportability decision for the complaint.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: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899152
• Report Number: 1417592-2026-51119
• Device Sequence Number: 16142061
• Product Code: EYJ
• 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): 09/24/2026

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: SNAPSECURE3W
• Device Lot Number: 67024044502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2025
• 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: 12/06/2024
• Initial Report FDA Received Date: 09/25/2026
• 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