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

Catalog Number	HCSPUPPY
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact, "nebulizer takes an hour to mist and to get through a treatment for her young child." the customer contact stated her daughter "missed treatment" as a result of the nebulizer "not properly misting." the customer confirmed that there was no serious injury or medical treatment required.No additional information is available at this time.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 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 customer contact, "nebulizer takes an hour to mist and to get through a treatment for her young child." the customer contact stated her daughter "missed treatment" as a result of the nebulizer "not properly misting.".

• Brand Name: MEDLINE
• Common Device Name: COMPRESSOR,NEBULIZER, CHARACTER, PUPPY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24575354
• Report Number: 1417592-2026-00211
• Device Sequence Number: 9232602
• Product Code: BTI
• UDI-Device Identifier: 00888277678166
• UDI-Public: 00888277678166
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: Other
• Device Catalogue Number: HCSPUPPY
• Device Lot Number: 6462504
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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 Age: 4 MO
• Patient Sex: Female