MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 16FR 100% SIL TEMP CATH W/UM

Catalog Number	UROT1058H
Medical Device Problem Codes	Break (1069); Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6), observed foley in pieces on the bed, drain intact in patient and tubing disconnected.Replaced foley.No additional information at this time.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 (b)(6), observed foley in pieces on the bed, drain intact in patient and tubing disconnected.Replaced foley.

• Brand Name: MEDLINE
• Common Device Name: 16FR 100% SIL TEMP CATH W/UM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; three lakes dr; northfield, IL 60093 ; 2173279112
• MDR Report Key: 24485954
• Report Number: 1417592-2026-00167
• Device Sequence Number: 13432373
• Product Code: OHR
• UDI-Device Identifier: 10193489604931
• UDI-Public: 10193489604931
• 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
• Report Date (Section B): 03/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UROT1058H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/02/2026
• 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