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

Catalog Number	HCS4483H
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, she received a new mouthpiece and when using it, was "dripping clear fluid" from the cap.
Additional Manufacturer Narrative
According to the customer, she received a new mouthpiece and when using it, was "dripping clear fluid" from the cap.The customer reported she uses the nebulizer to take medication for her "asthma".The customer reported she "assumes the fluid leaking is the medication".The customer reported despite the reported issue her asthma symptoms are improving.The customer reported there was no serious injury, medical intervention, or follow up care required as a result of the reported incident.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.

• Common Device Name: NEBULIZER,KIT,T-MOUTHPIECE,6RESER,7TUB
• 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: 19116504
• Report Number: 1417592-2024-00510
• Device Sequence Number: 7141370
• Product Code: CAF
• UDI-Device Identifier: 10080196715541
• UDI-Public: 10080196715541
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/16/2024

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: HCS4483H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/16/2024
• 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