MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CATHETER-2026-202-200712701

Catalog Number	URO2S0615TK
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on or about (b)(6) 26 to (b)(6) 26, two separate events involving different nicu patients on ecmo.In both cases, 6 fr temperature sensing catheters were used, and upon removal of paralytics, the patients' bladders were noted to fill with air.The air was manually removed but returned again.Urine drainage was reported as normal, and staff noted that air was entering the bladder.X rays reportedly showed air infiltration.The facility reported no similar issues when using 8 fr temperature sensing catheters.It has been determined that the reported event caused or contributed to serious injury, therefore, 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 or about (b)(6) 26 to (b)(6) 26, two separate events involving different nicu patients on ecmo.In both cases, 6 f temperature sensing catheters were used, and upon removal of paralytics, the patients' bladders were noted to fill with air.According to the facility on or about (b)(6) 26 to (b)(6) 26, two separate events involving different nicu patients on ecmo.In both cases, 6 f temperature sensing catheters were used, and upon removal of paralytics, the patients' bladders were noted to fill with air.

• Brand Name: MEDLINE
• Common Device Name: CATHETER-2026-202-200712701
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24558734
• Report Number: 1417592-2026-00202
• Device Sequence Number: 21360851
• Product Code: OHR
• UDI-Device Identifier: 10888277875050
• UDI-Public: 10888277875050
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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
• Device Catalogue Number: URO2S0615TK
• Device Lot Number: 25IBI661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2025
• 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; Required Intervention
• Patient Sex: Unknown