MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,SILI-ELAST,LTX,18FR,10ML

Catalog Number	DYND11758
Medical Device Problem Codes	Deflation Problem (1149); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025, during a routine foley catheter change at the 30-day mark, the "catheter balloon would not deflate.".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, during a routine foley catheter change at the 30-day mark, the "catheter balloon would not deflate." the customer stated that "multiple nurses tried, and could not get the balloon to deflate, we even cut the entire end of the catheter to try and manually deflate.That did not work either." the customer reported that the patient was taken to the emergency room where the balloon was "deflated via guide wire." it has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Additional Manufacturer Narrative
Update to investigation h6: type of investigation (b).Update to investigation h6: investigation findings (c).Update to investigation h6: investigation conclusions (d).

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,18FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22494816
• Report Number: 1417592-2025-00333
• Device Sequence Number: 14489654
• Product Code: EZL
• UDI-Device Identifier: 10080196726530
• UDI-Public: 10080196726530
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/29/2025

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?: No
• Device Catalogue Number: DYND11758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 80 KG