MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; COMPRESSOR,NEBULIZER, PUPPY, RD, PRODUCT CODE: BTI

Catalog Number	HCSPUPPYRD
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, the nebulizer stopped working and it has no pressure.
Additional Manufacturer Narrative
Detailed description of the event: according to the customer, it was reported that the nebulizer stopped working and it has no pressure.There were no reports of death, serious injury, medical intervention, or follow up care.Based on the information reviewed, the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could be likely to cause or contribute to a death or serious injury.An mdr submission was required and has been completed and documented.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.

• Brand Name: MEDLINE
• Common Device Name: COMPRESSOR,NEBULIZER, PUPPY, RD, PRODUCT CODE: BTI
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: jordan williams ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25087118
• Report Number: 1417592-2026-00913
• Device Sequence Number: 16095616
• Product Code: BTI
• UDI-Device Identifier: 00888277697198
• UDI-Public: 00888277697198
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: HCSPUPPYRD
• Device Lot Number: 6462406
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown