MAUDE Adverse Event Report: VYAIRE MEDICAL WATER STERILE F/INHALATION 2000ML 6/CS; STERILE SOLUTION STORAGE BOTTLE, SINGLE-USE

Model Number WATER STERILE F/INHALATION 2000ML 6/CS

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

The customer reported to vyaire medical that there was a rust-colored or dark-red substance attached to the to the humidification chamber's inner plastic and floating inside the water of the humidification chamber while on a patient.No harm is associated with the event.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Result of investigation: the suspect device was not returned for evaluation.The reported lot number and retained samples were tested and no trace of contamination were detected.No samples were returned and was unable to further investigate the complaint.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: WATER STERILE F/INHALATION 2000ML 6/CS
• Type of Device: STERILE SOLUTION STORAGE BOTTLE, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): LABORATORIOS PISA; sa de cv carretera san isidro; 7000 tlajomulco de zuniga; jalisco, 45645 ; MX 45645
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15154086
• MDR Text Key: 304702347
• Report Number: 3013421741-2022-00019
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10885403026607
• UDI-Public: (01)10885403026607(10)Q2201058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090915
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WATER STERILE F/INHALATION 2000ML 6/CS
• Device Catalogue Number: 2D0737
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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