MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH MICROGARD II BACT/VIRAL FILTER; Filter, bacterial, breathing-circuit

Model Number	MICROGARD II BACT/VIRAL FILTER
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire on (b)(6)2024 that a lung injury occurred while inhaling during a spirometry measurement.During a forced spirometry measurement for a nocion chronic cough study using the microgard ii filter, the test patient felt like she had inhaled something from the device.As a result, the patient had to cough and the voice became unusual and irritated.A doctor examined her throat and listened to her lungs and suggested that she go to the er for a ct scan because he believed that she had a tracheal tear.A ct scan showed that she did have a tracheal tear.A surgeon was consulted and after two days of observation, it was determined that she would not need surgery.After two days the test patient was discharged from the hospital.The site coordinator conducting the test inspected the machine and all devices that were attached but did not observe anything unusual.
Additional Manufacturer Narrative
On (b)(6)2025 the affected filter and another sealed filter from the same lot arrived and were investigated by a product manager.A visual examination was performed and no abnormalities were detected.In addition, a test was performed in which compressed air was passed through the filter to detect small defects in the filter fleece.This test also could not confirm any damages on the filter.Further tests will be performed and further information is requested from the customer to identify the cause of this event.A follow up report will be submitted as soon as further information is available.The risk evaluation results in a risk acceptance level of a medium acceptable health risk.

• Brand Name: MICROGARD II BACT/VIRAL FILTER
• Common Device Name: Filter, bacterial, breathing-circuit
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): RIENSCH & HELD GMBH & CO. KG; hans-duncker-str. 1; hamburg 21035 ; GM 21035
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 21158669
• Report Number: 9615102-2025-00163
• Device Sequence Number: 12870071
• Product Code: CAH
• UDI-Device Identifier: 14250892903115
• UDI-Public: (01)14250892903115
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: FDA PREMARKE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MICROGARD II BACT/VIRAL FILTER
• Device Catalogue Number: V-892381
• Device Lot Number: RB62303149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female