MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 6FR 1.5ML TEMP SENS CATH W/3ML

Catalog Number	URO2S0615TK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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	Malfunction
Additional Manufacturer Narrative
"according to the facility, a 6 fr temperature sensing catheter was used on a nicu patient on ecmo, and upon removal of paralytics, the patient's bladder was 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 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, a 6 fr temperature sensing catheter was used on a nicu patient on ecmo, and upon removal of paralytics, the patient's bladder was noted to fill with air.".
Additional Manufacturer Narrative
Update to d9, h3, and h6.After further investigation, the sample was returned to and evaluated by the manufacturer on 03/05/2026.The investigation involved historical data analysis and testing of the actual/suspected device.The investigation concluded that no device problem was found and that no problem was detected.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: 6FR 1.5ML TEMP SENS CATH W/3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 24552260
• Report Number: 1417592-2026-00203
• Device Sequence Number: 5725506
• Product Code: OHR
• UDI-Device Identifier: 10888277875050
• UDI-Public: 10888277875050
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2026

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: URO2S0615TK
• Device Lot Number: 25IBI661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/05/2026
• 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
• Patient Sex: Unknown