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

Catalog Number	DYND11533
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "the balloon is bursting after about 24 hours of use.Due to this the device was removed and replaced.Due to the reported problem/issue, and in an abundance of caution, an adverse event report will be filed.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
Foley balloon rupturing.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22045705
• Report Number: 1417592-2025-00231
• Device Sequence Number: 13026979
• Product Code: EZL
• UDI-Device Identifier: 10884389034552
• UDI-Public: 10884389034552
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/19/2025

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 Expiration Date: 08/28/2025
• Device Catalogue Number: DYND11533
• Device Lot Number: 59220091894
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/19/2025
• 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