MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CATHETER,FOLEY,100%SILICONE,16FR,10ML,LF

Catalog Number	DYND11502H
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, 5 days after a routine catheter change, the patient "presented to the er stating that the previous day she felt a pop and her catheter fell out shortly thereafter." a new catheter was placed.No report of serious injury.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, 5 days after a routine catheter change, the patient "presented to the er stating that the previous day she felt a pop and her catheter fell out shortly thereafter.".

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,100%SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23915431
• Report Number: 1417592-2025-00750
• Device Sequence Number: 9093180
• Product Code: EZL
• UDI-Device Identifier: 10884389034538
• UDI-Public: 10884389034538
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11502H
• Device Lot Number: 592250505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/29/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 63 KG