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

Catalog Number HCS4483H

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  Injury  

Event Description

According to the customer, she received a new mouthpiece and when using it, was "dripping clear fluid" from the cap.

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.

• Type of Device: 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
• MDR Text Key: 340283599
• Report Number: 1417592-2024-00510
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10080196715541
• UDI-Public: 10080196715541
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: HCS4483H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other