MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF

Catalog Number	DYND11532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, a 30 cc foley catheter ruptured while being used for iol.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.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 facility, a 30 cc foley catheter ruptured while being used for iol.
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved historical data analysis and trend analysis, and that the device was not returned.The investigation identified a usage problem, and the cause was traced to the user.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update to d9, h3, and h6.After further investigation, it has been determined that the investigation involved testing of the actual device, an analysis of production records, a historical data analysis, and a trend analysis.A sample of the reported product was returned and evaluated on 4/21/26.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 24583530
• Report Number: 1417592-2026-00220
• Device Sequence Number: 10391213
• Product Code: EZL
• UDI-Device Identifier: 10080196170982
• UDI-Public: 10080196170982
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082815
• 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,Followup,Followup
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYND11532
• Device Lot Number: 59225051428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/21/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/05/2026; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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
• Patient Sex: Unknown