MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF

Catalog Number	DYND11533
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6) 2025 "the patient complained of bladder pain and said that she felt like she had used the bathroom on herself, when the nurse assessed her foley, it was hanging out of the patient with the balloon deflated".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 "the patient complained of bladder pain and said that she felt like she had used the bathroom on herself, when the nurse assessed her foley, it was hanging out of the patient with the balloon deflated".Per the facility "the nurse tried to reinflate with 10cc's of normal saline and the balloon was leaking due to a hole in it, the nurse was able to insert a new 18fr foley with no issues noted".The sample is not available for evaluation.No additional information is available at this time.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.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21857887
• Report Number: 1417592-2025-00181
• Device Sequence Number: 20805450
• Product Code: EZL
• UDI-Device Identifier: 10884389034552
• UDI-Public: 10884389034552
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/17/2025

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: DYND11533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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