MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; BAG,DRAINAGE,UROLOGY,2000ML,ANTI REFLUX

Catalog Number	DYNC1674
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, the foley is not draining well which causes increased sediment and increased catheter blocking.This results in increased foley changes and increased testing of urine for utis.There was no further information.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.Due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was requested for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
According to the facility, the foley is not draining well which causes increased sediment and increased catheter blocking.

• Brand Name: MEDLINE
• Common Device Name: BAG,DRAINAGE,UROLOGY,2000ML,ANTI REFLUX
• 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: 24476367
• Report Number: 1417592-2026-00162
• Device Sequence Number: 21227689
• Product Code: KNX
• UDI-Device Identifier: 10080196840922
• UDI-Public: 10080196840922
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/27/2026

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: DYNC1674
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/27/2026
• 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