MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HUMIDIFIER,EMPTY,STANDARD,500ML,4 PSI

Catalog Number	HUD3230
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a "burnt mark on top of bottle.".
Additional Manufacturer Narrative
The account reported finding the unit was received "damaged," and the complaint description was "burnt mark on top of bottle." a photograph was provided for the investigation, and the picture shows a part of the cap melted.The reported problem was confirmed by the photograph; cause was documented as "dc: unknown responsible party" and "cannot determine cause w/received sample." the division will monitor for trends.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: HUMIDIFIER,EMPTY,STANDARD,500ML,4 PSI
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: arthem smalyukh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50923404
• Report Number: 1417592-2026-52593
• Device Sequence Number: 17475383
• Product Code: BTT
• UDI-Device Identifier: 10197344009756
• UDI-Public: 10197344009756
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230559
• 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): 09/25/2026

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
• Device Catalogue Number: HUD3230
• Device Lot Number: (10)24EOA141
• Was Device Available for Evaluation?: No
• 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: 02/21/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown