MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; COMPRESSOR, REUS AND DISP NEBULIZER KIT

Catalog Number	HCS70004RD
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was "not putting out any air, the medicine is not moving at, no air comes out of the mouthpiece.It is on, it is running, it is not pushing out enough air to be effective.".
Additional Manufacturer Narrative
According to the customer, the nebulizer doesn¿t have "enough power" to consistently nebulize the medication; the device turns on but does not produce a steady stream of vapor, and the user has not incurred a serious injury and has not missed a medication as they¿ve been able to use their albuterol inhaler.Medline quality received one unit, visually inspected the sample and observed a clean filter, plugged the sample into a power source and turned it on; the sample turned on and it did mist, a digital flowmeter reading was 8 lpm, which meets product specifications, and the sample was opened to check for internal damages and defects.The reported issue was not confirmed with 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, 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: COMPRESSOR, REUS AND DISP NEBULIZER KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947535
• Report Number: 1417592-2026-54458
• Device Sequence Number: 9499662
• Product Code: BTI
• UDI-Device Identifier: 00888277415068
• UDI-Public: 00888277415068
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: HCS70004RD
• Device Lot Number: 6462311
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2024
• 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: 11/27/2024
• Initial Report FDA Received Date: 09/30/2026
• 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