MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ MISTY MAX 10¿ NEBULIZER, MEDICATION SYSTEM WITH FILTER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	AIRLIFE¿ MISTY MAX 10¿ NEBULIZER, MEDICATION SYSTEM WITH FILTER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not available for return, as it was discarded after the treatment.No further evaluation can be completed at this time.Any additional information received from the customer will be included in a follow-up report.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that during treatment of albuterol/pentamidine the airlife misty max nebulizer had a multiple medication leak issue during patient use.The medication is getting through the middle filter on the device/tubing and pooling.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Results of investigation:the customer did not send pictures or the physical sample for the investigation therefore the reported defect was not confirmed.The device history record for the part number 002450 with lot number 0004147582 and udi (b)(4) was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured, inspected and released on 30jun2020 per our internal procedures and no issues were found.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE¿ MISTY MAX 10¿ NEBULIZER, MEDICATION SYSTEM WITH FILTER
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14432018
• Report Number: 8030673-2022-00245
• Device Sequence Number: 12420772
• Product Code: CAF
• UDI-Device Identifier: 10190752114944
• UDI-Public: (01)10190752114944(10)0004147582
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K023602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE¿ MISTY MAX 10¿ NEBULIZER, MEDICATION SYSTEM WITH FILTER
• Device Catalogue Number: 002450
• Device Lot Number: 0004147582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown