MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; COMPRESSOR,NEBULIZER,AEROMIST, ADLT MASK

Catalog Number	HCS70004ADLT
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the medication in his nebulizer "bubbles" in the chamber but is not coming out of the "mouthpiece".The customer reported he changed the filter, but the issue was not resolved.The customer reported he has been without his "budesonide inhalation suspension 0.5" for "5-6 days".The customer reported the prescription indicates administration of the medication "daily", and without the medication he is having "trouble breathing when walking around outside".The customer reported he is now "getting short of breath much quicker than normal".The customer reported no serious injury, medical intervention, or follow-up care needed related to the reported incident.Sample requested for return evaluation.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, the medication in his nebulizer "bubbles" in the chamber but is not coming out of the "mouthpiece".

• Common Device Name: COMPRESSOR,NEBULIZER,AEROMIST, ADLT MASK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19088845
• Report Number: 1417592-2024-00487
• Device Sequence Number: 7112689
• Product Code: BTI
• UDI-Device Identifier: 10888277703759
• UDI-Public: 10888277703759
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/11/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: HCS70004ADLT
• Device Lot Number: 6462305
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown