MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; NEBULIZER,KIT,T-MOUTHPIECE,6RESER,7TUB

Catalog Number	HCS4483
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas Output Problem (1266); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "the nebulizers do not produce an aerosol and leak out the bottom, despite changing the nebulizer every single treatment." the facility reports they "feel like patients are not getting their full dose of medication.These nebulizers leak out the bottom consistently.If you use it more than once, it either does not mist and/or leaks." the facility reports "no patient harm." it has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 facility, "the nebulizers do not produce an aerosol and leak out the bottom, despite changing the nebulizer every single treatment.".
Additional Manufacturer Narrative
Updated h3: device evaluated by manufacturer.Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).

• Brand Name: MEDLINE
• Common Device Name: NEBULIZER,KIT,T-MOUTHPIECE,6RESER,7TUB
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; three lakes dr; northfield, IL 60093 ; 2173279112
• MDR Report Key: 24241258
• Report Number: 1417592-2026-00079
• Device Sequence Number: 10229246
• Product Code: CAF
• UDI-Device Identifier: 10080196715541
• UDI-Public: 10080196715541
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K091272
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: Health Professional
• Device Catalogue Number: HCS4483
• Device Lot Number: 01525040236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown