MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYRTR 16FR10ML LATEX UM SNAP

Catalog Number	URO175216
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when it was time to remove the foley, the balloon would not deflate.Once syringe was attached the fluid could not be pulled back.
Additional Manufacturer Narrative
The customer reported multiple incidents of foley balloons not deflating, including that the nurse had to cut the foley above the y bifurcation to get the balloon to deflate and that in another case the foley had to be removed with the balloon intact from the patient; the complaint states patient 3 was harmed.Medline quality received 1 ea of the reported product in unpackaged, unused condition; visual assessment revealed no defects nor abnormalities, dimensional analysis found that product dimensions were within specified criteria, and functional testing found the balloon inflated without issue, was free of deformity, and deflated without incident with the entire volume of water returned to the syringe.The reported issues could not be verified based on visual or functional inspection of the received sample.No root cause was identified; a device history record review found no notable issues, a retrospective post-market review revealed no additional complaints of deflation failure with respect to the product, and medline quality will continue to monitor for the issue through complaint meetings and 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: 1LYRTR 16FR10ML LATEX UM SNAP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691728
• Report Number: 1417592-2026-34746
• Device Sequence Number: 5891749
• Product Code: OHR
• UDI-Device Identifier: 40193489987394
• UDI-Public: 40193489987394
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/04/2026

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: URO175216
• 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: 03/21/2024
• Initial Report FDA Received Date: 09/09/2026
• 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