MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TR1LYR 6FR 3ML100%SILIPEDS UM

Catalog Number	DYND160806
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the 6ft medline foley has broken at the y site junction on 2 occasions while in patients in the picu.".
Additional Manufacturer Narrative
The customer reported the foley had broken at the y site junction on 2 occasions while in patients in the picu.Medline quality received photographs documenting the issue, as well as additional samples pulled from the supply room, and the products were received in packaged, unused condition; visual assessment of the provided photograph revealed that the pediatric foley catheter was ripped at the y junction.The reported issue was verified by visual assessment of the photograph, thus confirming the reported complaint.The cause remains classified as unknown responsible party, cannot determine cause with received sample, and there was no medical intervention or serious injury reported related to this incident.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: TR1LYR 6FR 3ML100%SILIPEDS UM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50806910
• Report Number: 1417592-2026-43953
• Device Sequence Number: 10610615
• Product Code: OHR
• UDI-Device Identifier: 40884389118901
• UDI-Public: 40884389118901
• 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): 09/17/2026

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: DYND160806
• Device Lot Number: 22JBU753
• 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: 02/07/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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