MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4

Catalog Number	780-13
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during use in the neonatal intensive care unit, a large amount of fluid accumulated inside the hudson rci brand heated breathing circuit set.
Additional Manufacturer Narrative
According to the customer contact, during use in the neonatal intensive care unit, a large amount of fluid accumulated inside the hudson rci brand heated breathing circuit set, and the customer reported "none" to any "health effects, clinical signs, symptoms, conditions as well as overall health impact." no sample or photo was received for the investigation; the complaint was provided to the manufacturing site for further evaluation, and the device history record was reviewed and confirmed that the product was assembled and inspected in accordance with approved specifications, with no nonconformance reports or manufacturing discrepancies identified that could be associated with the reported issue.The reported problem could not be confirmed because no sample or photo was received, and due to the absence of a returned sample, a definitive root cause could not be determined.The quality team will monitor this issue for trending purposes, and there has been no change to the reportability decision associated with this complaint.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50933217
• Report Number: 1417592-2026-53190
• Device Sequence Number: 13443102
• Product Code: BZO
• UDI-Device Identifier: 14026704660008
• UDI-Public: 14026704660008
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: 780-13
• Device Lot Number: 74H2201543
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown