MAUDE Adverse Event Report: VYAIRE MEDICAL WATER STERILE FOR INHALATION 500ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number WATER STERILE FOR INHALATION 500ML

Device Problem Device Emits Odor (1425)

Patient Problem Cough (4457)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.If additional information becomes available.

Event Description

The customer reported that the cn0005 water sterile for inhalation 500m, water smells like fruit punch and is making the patient cough a lot.

• Brand Name: WATER STERILE FOR INHALATION 500ML
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): LABORATORIOS PISA S.A. DE C.V.; calle 7 n0. 1308; zona industrial; guadalajara jalisco, 44940 ; MX 44940
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14190933
• MDR Text Key: 289952851
• Report Number: 3005440755-2022-00001
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752141780
• UDI-Public: (01)10190752141780(10)ZI-2108234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WATER STERILE FOR INHALATION 500ML
• Device Catalogue Number: CN0005
• Device Lot Number: ZI-2108234
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other