MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYR TRY 14FR 10ML 100% SIL TMP SNAP

Catalog Number	URO175814TS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "foley is clogged and not draining.Protocol is to remove the catheter and replace with a new one.Upon removal, they noticed clogging in the tip of the catheter.No injuries reported to the patient." 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, "foley is clogged and not draining.Protocol is to remove the catheter and replace with a new one.Upon removal, they noticed clogging in the tip of the catheter.No injuries reported to the patient.".
Additional Manufacturer Narrative
Updated h3: device evaluated by manufacturer.Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).

• Brand Name: MEDLINE
• Common Device Name: 1LYR TRY 14FR 10ML 100% SIL TMP SNAP
• 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: 24282816
• Report Number: 1417592-2026-00094
• Device Sequence Number: 18287725
• Product Code: OHR
• UDI-Device Identifier: 10193489987539
• UDI-Public: 10193489987539
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: URO175814TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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