MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TRAY,1LYR 8FR5ML 100%SIL URN METER

Catalog Number	URO170808
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, the sample port detached on the catheter and catheter was replaced.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, the sample port detached on the catheter and catheter was replaced.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, after a urine sample was drawn and while removing the "leur-lock sampling port" on the foley tubing "the entire sampling port broke out of the foley, leaving an open hole in the catheter tubing." the customer stated that the "entire foley and bag closed system had to be removed and replaced with a new set." the customer reported the patient is "deceased" but confirmed that the patient death was not related to the reported device issue.The customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.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.Update to a2: age at time of event.Update to a3a: sex.Update to a4: weight.Update to b1.Update to b5: describe event or problem.Update to d1: brand name.Update to d4: lot #, expiration date.Update to e1: name and address.Update to e4: initial reporter also sent report to fda? update to g4: premarket identification.Update to h1: type of reportable event.Update to h4: device manufacture date.Update to h6: health effect (e).Update to h10: related report numbers.Update to h11: additional manufacturing narrative.
Event or Problem Description
According to the customer, on (b)(6) 2025, after a urine sample was drawn and while removing the "leur-lock sampling port" on the foley tubing "the entire sampling port broke out of the foley, leaving an open hole in the catheter tubing." the customer stated that the "entire foley and bag closed system had to be removed and replaced with a new set." the customer reported the patient is "deceased" but confirmed that the patient death was not related to the reported device issue.

• Brand Name: MEDLINE
• Common Device Name: TRAY,1LYR 8FR5ML 100%SIL URN METER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23582551
• Report Number: 1417592-2025-00639
• Device Sequence Number: 9532707
• Product Code: OHR
• UDI-Device Identifier: 10889942213467
• UDI-Public: 10889942213467
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/09/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: URO170808
• Device Lot Number: 25DBL678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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 Age: 12 MO
• Patient Sex: Female
• Patient Weight: 14 KG