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

Catalog Number	SNAPSECURE3W
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during bath, rn changed stat-lock for patient's foley.2, 3-way foley attempted, neither would secure closed.".
Additional Manufacturer Narrative
The customer reported that during a bath, the rn changed stat-lock for the patient's foley; 2, 3-way foley attempted, neither would secure closed, and no harm to the patient has been reported.Medline quality received 2 ea of the reported product in unpackaged, used condition; visual assessment revealed that the hooks on the securement devices were bent forward and malformed, and functional testing was then conducted by attempting to close the snapsecures.The reported issue of failures to close was verified by visual assessment of the provided samples, and both samples were not able to fully close due to the bent hooks, verifying the reported issue.Based on the provided sample and the description of the issue, the root cause is a manufacturing defect creating misalignment of the hooks/latch; there are currently no known trends for this product lot, and medline quality will continue to monitor for the issue through bi-weekly complaint meetings and quarterly trending analysis.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: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858605
• Report Number: 1417592-2026-48122
• Device Sequence Number: 9953616
• Product Code: EYJ
• UDI-Device Identifier: 20193489102717
• UDI-Public: 20193489102717
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/22/2026

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: 24GBK993
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2024
• 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: 11/18/2024
• Initial Report FDA Received Date: 09/22/2026
• 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