MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 8FR 3ML CATH W/5ML STER WATER

Catalog Number	URO2S0803K
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on 2/12/2026, there was an order placed by the pa to remove a foley.5ml of saline was removed from the balloon, but resistance was felt when trying to remove the catheter.Physicians were paged.A cystogram was ordered which was normal.The patient was encouraged to ambulate and let gravity assist with catheter dislodgement.At approximately 1830, the catheter finally fell out while the patient was ambulating.Upon inspection of the catheter, all parts/pieces were intact, but there was cuffing noted at the area of the balloon.No bleeding or abnormal discharge from patient.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.
Event or Problem Description
According to the facility on 2/12/2026, there was an order placed by the pa to remove a foley.5ml of saline was removed from the balloon, but resistance was felt when trying to remove the catheter.
Additional Manufacturer Narrative
Updated h6- c.

• Brand Name: MEDLINE
• Common Device Name: 8FR 3ML CATH W/5ML STER WATER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24802679
• Report Number: 1417592-2026-00377
• Device Sequence Number: 9944710
• Product Code: OHR
• UDI-Device Identifier: 10888277561298
• UDI-Public: 10888277561298
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/14/2026

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
• Device Catalogue Number: URO2S0803K
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown