MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; BALLOON BUTTON,MEDLINE,ENFIT,18FR,2.0CM

Catalog Number	ENFIT331820
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient called stating, "that the balloon has a leakage and is causing her to get irritation can we replace her this item." 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.
Event or Problem Description
Patient called stating, "that the balloon has a leakage and is causing her to get irritation can we replace her this item.".

• Brand Name: MEDLINE
• Common Device Name: BALLOON BUTTON,MEDLINE,ENFIT,18FR,2.0CM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brookie jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24746729
• Report Number: 1417592-2026-00331
• Device Sequence Number: 8772676
• Product Code: PSH
• UDI-Device Identifier: 10193489143676
• UDI-Public: 10193489143676
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ENFIT331820
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 03/31/2026
• 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
• Patient Sex: Unknown