MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYRTR 14FR10ML LATEX DB SNAP

Catalog Number	URO175114
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, on (b)(6) 2025 the foley was "leaking around the urinary meatus, and not 100% draining into the bag".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 the foley was "leaking around the urinary meatus, and not 100% draining into the bag".The customer reported that "physical manipulation used to attempt for regain flow of urine in drainage system" with no resolve requiring an additional foley to be inserted.The customer reported that the foley was inserted on (b)(6) 2025 utilizing 10 cc of sterile saline.The customer did not report any serious injury related to the reported incident.No additional details are available related to the customer reported issue.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.

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 14FR10ML LATEX DB SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24242045
• Report Number: 1417592-2026-00081
• Device Sequence Number: 13309044
• Product Code: OHR
• UDI-Device Identifier: 10193489987119
• UDI-Public: 10193489987119
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: URO175114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 77 KG