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

Catalog Number	HCS70004RD
Medical Device Problem Codes	Fluid/Blood Leak (1250); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "cords are leaking and the power is weaker and can be heard that it is not as strong.".
Additional Manufacturer Narrative
The complaint description was ¿tubing leaking and power is weak,¿ and the customer called in stating that ¿she only needs the tubes¿ and ¿the machine works fine.¿ a sample was received; medline visually inspected the sample and observed that the jet nebulizer kit was in used condition with tape wrapped around the tubing, the nebulizer compressor appeared to be in good condition but the filter was due for replacement, the sample turned on with a loud buzzing sound and misted, the digital flowmeter reading was 4.6 lpm, and debris inside and a loose piston bolt were observed.The 4.6 lpm reading did not meet product specifications, and medline confirmed that the unit contains debris; the leaking-fluid defect was documented with ¿unconfirmed defect - see investigation summary.¿ based on the complaint details, the root cause is considered to be a vendor product issue relating to the manufacturing process, while the investigation also stated that this kind of damage is typically caused from not properly maintaining the compressor, and medline stated that the vendor is already aware of the issue and 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, 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: 50931974
• Report Number: 1417592-2026-52992
• Device Sequence Number: 13451782
• Product Code: BTI
• UDI-Device Identifier: 10888277415065
• UDI-Public: 10888277415065
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/28/2026

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: 6461908
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2023
• 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: 11/07/2023
• 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