MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR 18FR10MLC100%SIL UMSSNP

Catalog Number	URO175818CS
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the foley balloon "ruptured" causing a return of "blood" into the catheter, removal of the catheter, and utilization of "cystoscopy" for placement of an additional catheter.The customer did not report any serious injury related to the reported incident.No additional information is available.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.Incident information received by fda under medwatch#: mw5162708.Initial reporter chose to remain confidential.No customer information available to manufacturer.
Event or Problem Description
According to the customer, the foley balloon "ruptured" causing a return of "blood" into the catheter, removal of the catheter, and utilization of "cystoscopy" for placement of an additional catheter.

• Common Device Name: 1LYRTR 18FR10MLC100%SIL UMSSNP
• 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: 21092040
• Report Number: 1417592-2025-00009
• Device Sequence Number: 13047878
• Product Code: OHR
• UDI-Device Identifier: 40193489987561
• UDI-Public: 40193489987561
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: 09/30/2025
• Device Catalogue Number: URO175818CS
• Device Lot Number: 24IBT968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/07/2025
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White