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

Device Problem Leak/Splash (1354)

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

Event Date 03/29/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 293151241
• Report Number: 8030673-2022-00245
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752114944
• UDI-Public: (01)10190752114944(10)0004147582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1