MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CATHETER,FOLEY,3-WAY,18FR,30ML,100% SILI

Catalog Number	DYND11573
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025, the product was being used by an experienced nurse practitioner for urology who states that this "foley catheter could not be placed in a patient.Had to use alternative catheter".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 on (b)(6) 2025, the product was being used by an experienced nurse practitioner for urology who states that this "foley catheter could not be placed in a patient.".

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,3-WAY,18FR,30ML,100% SILI
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24261666
• Report Number: 1417592-2026-00086
• Device Sequence Number: 8010188
• Product Code: EZL
• UDI-Device Identifier: 10884389119532
• UDI-Public: 10884389119532
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: DYND11573
• Device Lot Number: 59224113429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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