MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML

Catalog Number	DYND11756
Medical Device Problem Codes	Break (1069); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Urinary Retention (2119); Foreign Body In Patient (2687)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "the catheter was not draining.".The nozzle was replaced, then later it was noticed that "the valve broke off inside the patient.".The customer went to the emergency room, an ultrasound was performed and "they could see the piece of catheter was still inside the bladder.".Customer was admitted to the hospital and subsequently had a cystoscopy done to remove the piece of catheter.No additional information at this time.The product has been requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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 customer, "the catheter was not draining.".The nozzle was replaced, then later it was noticed that "the valve broke off inside the patient.".The customer went to the emergency room, an ultrasound was performed and "they could see the piece of catheter was still inside the bladder.".Customer was admitted to the hospital and subsequently had a cystoscopy done to remove the piece of catheter.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML
• 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: 23317159
• Report Number: 1417592-2025-00559
• Device Sequence Number: 14694427
• Product Code: EZL
• UDI-Device Identifier: 10080196726523
• UDI-Public: 10080196726523
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other
• Type of Report: Initial
• 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: DYND11756
• Device Lot Number: 592250402
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female