MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYRTR 16FR10ML 100%SILI SNAP

Catalog Number	URO175716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, after instilling chemotherapy through the foley catheter on (b)(6) 2026, the balloon "popped" causing "pink tinged" urine and a "burning sensation".The customer reported that after the incident occurred the foley catheter was removed and there was "no harm to patient".The customer did not report any serious injury related to the reported incident.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Per email; ruptured foley catheter balloon inside patient, used for chemotherapy instillation (off-label).
Additional Manufacturer Narrative
Update to h6: type of investigation.Update to h6: investigation findings.
Additional Manufacturer Narrative
Updated b4: date of this report.Updated g2: report source.Updated g3: date received by manufacturer.

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 16FR10ML 100%SILI SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle pohlman ; three lakes drive; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24676482
• Report Number: 1417592-2026-00251
• Device Sequence Number: 18724863
• Product Code: OHR
• UDI-Device Identifier: 10193489987423
• UDI-Public: 10193489987423
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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?: No
• Device Catalogue Number: URO175716
• Device Lot Number: 25KBD341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 03/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 03/26/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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 Sex: Male