MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF

Catalog Number	DYND11500
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clogging of catheter.
Additional Manufacturer Narrative
The customer reported that they were experiencing constant clogging of 100% silicone foley catheters, even after inserting new products and after irrigation.No additional information was provided despite attempts to obtain.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional information becomes available this report will be reopened and reevaluated.
Additional Manufacturer Narrative
Updated b4, d2, d4, g3, g5, h2, h4.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18777387
• Report Number: 1417592-2024-00111
• Device Sequence Number: 14580928
• Product Code: EZL
• UDI-Device Identifier: 10080196801220
• UDI-Public: 10080196801220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/16/2025

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
• Device Catalogue Number: DYND11500
• Device Lot Number: 59223030318
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 09/21/2025
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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