MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYR 16FR10ML 100%SIL TMPST TR

Catalog Number	URO170816TS
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, "rn heard patient scream in pain.Rns went to bedside to assess patient.Patient reported feeling something "pop" inside her and said it was the catheter.Rn removed catheter and placed into trash.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, "rn heard patient scream in pain.Rns went to bedside to assess patient.Patient reported feeling something "pop" inside her and said it was the catheter.Rn removed catheter and placed into trash.Foley came out without issue, upon inspection foley balloon appeared to have "popped" bedside rn notified.Bedside rn went into room to assess.Patients' urethra appeared intact externally.There was no further information.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: 1LYR 16FR10ML 100%SIL TMPST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24491328
• Report Number: 1417592-2026-00171
• Device Sequence Number: 5092451
• Product Code: OHR
• UDI-Device Identifier: 10889942127955
• UDI-Public: 10889942127955
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: URO170816TS
• Device Lot Number: 25JBV896
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2025
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White