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

Catalog Number	URO2S0615TK
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we just had another episode of air in the bladder on one of our babies on ecmo with a temp sensing foley.The baby has a 6fr catheter in place.It was placed 8/4 but the air didn't accumulate until 8/13.The baby was leaking urine around the catheter last night, so they removed the fluid from the balloon and reinflated without incident.The air was noted on xray the following morning.".
Additional Manufacturer Narrative
It was reported that "we just had another episode of air in the bladder on one of our babies on ecmo with a temp sensing foley.The baby has a 6fr catheter in place.It was placed 8/4 but the air didn't accumulate until 8/13.The baby was leaking urine around the catheter last night, so they removed the fluid from the balloon and reinflated without incident.The air was noted on xray the following morning." there were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Brand Name: MEDLINE
• Common Device Name: 6FR 1.5ML TEMP SENS CATH W/3ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50681956
• Report Number: 1417592-2026-09729
• Device Sequence Number: 20125410
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: URO2S0615TK
• Device Lot Number: 26EBA711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2026
• Is the Device Labeled for Single Use? (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
• Patient Sex: Male
• Patient Weight: 5 LB
• Patient Race: Black Or African American