MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; COMPRESSOR,NEBULIZER, CHARACTER, PUPPY

Catalog Number	HCSPUPPY
Medical Device Problem Codes	Failure to Deliver (2338); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the attached neb is getting too hot and not dispensing medicine.".
Additional Manufacturer Narrative
The facility reported that on (b)(6) 2024, the nebulizer gets warm and doesn¿t dispense the medication; the user did not miss a treatment, and no medical intervention, serious injury, or follow-up care has been reported.Medline quality received one unit, visually inspected the sample, observed that the sample was received with a used filter, plugged the sample into a power source, and the sample turned on and misted; the digital flowmeter reading was 7.9 lpm, the unit arrived in good condition with all wires and tubing properly connected, the unit ran three times at 30 minute intervals without issue, and the average temperature was 88 degrees fahrenheit through the vent and 100 degrees fahrenheit with the cover off, which meets product specifications.The reported problem was not confirmed with the received sample, and medline was not able to confirm what may have caused the issue.The quality team will monitor this issue for trending purposes.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: COMPRESSOR,NEBULIZER, CHARACTER, PUPPY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931510
• Report Number: 1417592-2026-52900
• Device Sequence Number: 9734369
• Product Code: BTI
• UDI-Device Identifier: 00888277678166
• UDI-Public: 00888277678166
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 09/29/2026

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: HCSPUPPY
• Device Lot Number: 6462001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2025
• 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: 12/19/2024
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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