MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,SILI-ELAST,LTX,12FR,10ML

Catalog Number	DYND11752
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Client experienced difficulty during catheter removal at home due to balloon deflation failure.The nurse was unable to safely remove the catheter, prompting hospital transfer.At the hospital, attempts to deflate the balloon were unsuccessful.The catheter was ultimately snipped but did not drain.Ultrasound-assisted removal was required, during which the client experienced significant pain.Approximately 60cc of fluid was found in the balloon.
Additional Manufacturer Narrative
Client experienced difficulty during catheter removal at home due to balloon deflation failure.The nurse was unable to safely remove the catheter, prompting hospital transfer.At the hospital, attempts to deflate the balloon were unsuccessful.The catheter was ultimately snipped but did not drain.Ultrasound-assisted removal was required, during which the client experienced significant pain.Approximately 60cc of fluid was found in the balloon.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.
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved trend analysis and an analysis of production records.The investigation found a malfunction without a conclusive finding and a cause was not established.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,12FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23468860
• Report Number: 1417592-2025-00599
• Device Sequence Number: 18365339
• Product Code: EZL
• UDI-Device Identifier: 10080196726509
• UDI-Public: 10080196726509
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 12/15/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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: Unknown