MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYR 18FR10ML 100%SILI UMST TR

Catalog Number	URO170818S
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rn reported foley to be inserted, but deflated on 4 separate kits.
Additional Manufacturer Narrative
Medline quality received a complaint regarding foley balloons deflated during use.Medline quality did not receive a sample/pictures, and the investigation performed by the vendor found no abnormalities or defects in their production; a post-market retrospective review of the past 24 months revealed 0 additional complaints of similar catheter balloon issues and there are currently no known trends.The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.If a product is received or more information is made available, the complaint will be reopened and an investigation will be performed.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: 1LYR 18FR10ML 100%SILI UMST TR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50756382
• Report Number: 1417592-2026-39559
• Device Sequence Number: 15840412
• Product Code: OHR
• UDI-Device Identifier: 10889942126910
• UDI-Public: 10889942126910
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/09/2026

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: URO170818S
• Device Lot Number: 24KBF757
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2025
• 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: 03/06/2025
• Initial Report FDA Received Date: 09/14/2026
• 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