MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR 16FR10MLC100%SIL UM SNP

Catalog Number	URO175816C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the "bcg medication" was inserted into the bladder through the foley "side port" and after "35 minutes" the foley "came apart where the silicone meets the plastic tubing".The customer reported the medication leaked all over the patient's linens and bed causing the patient to be discharged home to "shower and wash clothing in hot water".The customer reported the medication was intended to remain in the bladder for "2 hours" and due to the reported issue, the patient did not receive the medication for the intended time.The customer reported the patient is fine.The customer did not report any serious injury, medical intervention, or follow-up care related to the reported event.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
According to the customer, the "bcg medication" was inserted into the bladder through the foley "side port" and after "35 minutes" the foley "came apart where the silicone meets the plastic tubing".

• Common Device Name: 1LYRTR 16FR10MLC100%SIL UM SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21509737
• Report Number: 1417592-2025-00117
• Device Sequence Number: 4449376
• Product Code: OHR
• UDI-Device Identifier: 10193489988727
• UDI-Public: 10193489988727
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/03/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2026
• Device Catalogue Number: URO175816C
• Device Lot Number: 24KBO453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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