MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH MICROGARD IIC 50 PCS; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	MICROGARD IIC 50 PCS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cough (4457)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspected filters have not been returned yet but were requested.Therefore, a definite rot cause has not been determined.Information from the customer and contract manufacturer are gathered to further investigate the issue.At the moment, not enough information are available to come to a final conclusion regarding the risk.It will be updated accordingly once the investigation reveals new information.Vyaire medical will submit a supplemental report if additional information becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire the following involving the microgard filter: the customer complained, that all patients tested on the reported event date kept mentioning that they felt something hitting the back of their throat whenever they did gas transfer.The health professionals (b)(6) decided to test it out by themselves and did their gas transfer a few times using different microgard filters.They found that with most of them, they felt like they were inhaling what they described as "small fibers" like you would do in a dusty environment.It made them cough, gag and choke and they felt the effects of it for the following couple of hours.
Additional Manufacturer Narrative
The microgard filters were returned to vyaire.Inhouse breathing tests could not reproduce the issue.The microgard filters were send to an external test lab for a chemical analysis.External lab results: the microgard ii filter was extracted in three extraction media with different polarity: polar, non-polar and semi-polar.In order to detect non-volatile, semi-volatile and volatile substances, the extractions were analysed using gas chromatography with mass spectroscopy (gc-ms) and ultra-pressure liquid chromatography (uplc).The results of the gc-ms analysis showed that no substance above the analytical evaluation threshold of 0.089 l was detected in the polar extraction (water).In the semi-polar extraction (isopropanol) 142.33 mg/device and in the non-polar extraction agent (hexane) 1046.84 mg/device were detected.In the uplc-ms, a total of 15.09 g substances per device were detected in water, 1.48 mg in isopropanol and 1.45 mg in hexane.In all studies, all test results were multiplied by two to obtain an additional safety factor.During the tests, three different extraction media with different polarities were tested, as the cells in the human body can have a different polarity.In the gc-ms extraction with water at 50°c no substances were released from the device, in the uplc only 15¿g/cm².Considering that some of the fibres enter areas of the body where semi-polar or non-polar conditions prevail, the risk of substances being released under these conditions is assessed.The overall risk for the patient when inhaling particles from the fibres of the microgard ii filter that reach the deep lung and leach out substances under nonpolar conditions in a concentration that is toxic to the patient is acceptable because the amount of substances is below the acceptable daily intake value specified for a cancer risk for long term devices, considering the patient inhales an amount of 500 fibre particles.The internal capa process regarding this complaint was closed as the risk was reassessed due to the provided information of the external lab.Therefore this incident is considered to be not reportable.The updated risk evaluation results in a risk acceptance level of a low acceptable health risk.
Event or Problem Description
It was reported to vyaire the following involving the microgard filter: the customer complained, that all patients tested on the reported event date kept mentioning that they felt something hitting the back of their throat whenever they did gas transfer.The health professionals steph and amber decided to test it out by themselves and did their gas transfer a few times using different microgard filters.They found that with most of them, they felt like they were inhaling what they described as "small fibers" like you would do in a dusty environment.It made them cough, gag and choke and they felt the effects of it for the following couple of hours.

• Brand Name: MICROGARD IIC 50 PCS
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): SAINT-GOBAIN PERFORMANCE PLASTICS L&S GMBH; am herrnberg 8; neuhaus; 98724 98724 ; GM 98724
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 17954122
• Report Number: 9615102-2023-00142
• Device Sequence Number: 20530679
• Product Code: CAH
• UDI-Device Identifier: 34250892903041
• UDI-Public: (01)34250892903041(10)L607788-27(11)230706
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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 IIC 50 PCS
• Device Catalogue Number: V-892384
• Device Lot Number: L 607788-27
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown