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 09/15/2021

Event Type  malfunction  

Event Description

The customer reported that the water sterile f/inhalation 2000ml 6/cs experienced deposits in the chamber during use.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has 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

Results of investigation: no sample was returned; therefore a definitive root cause could not be determined.During the dhr review it was corroborated that process parameters were executed according to the validated standards, raw materials and components used for the manufacturing were approved by the quality unit.Based on the aforementioned, it was determined that manufacturing process was not identified as a failure mode.Retention samples were also reviewed and residues of any type were not detected during the review of the samples.

• 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 S.A. DE C.V.; sa de cv carretera san isidro; 7000 tlajomulco de zúñiga; jalisco, 45645 ; MX 45645
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14459425
• MDR Text Key: 300324152
• Report Number: 3007502289-2022-00006
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10885403026607
• UDI-Public: (01)10885403026607(10)Q2104140
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 05/26/2022
• 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