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

Model Number	MICROGARD IIB
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is submitted late as the customer reported the incident in august 2024 to a vyaire employee but was not forwarded to the required department until 20-mar-2025.The filter was not returned for an investigation.A picture of the affected filter confirmed that the edges of the mouthpiece look deformed.The supplier was informed about the incident but cannot make any assumptions on anomalies during production, as the batch number was not provided by the customer.The supplier also reviewed the provided picture of the affected filter and assumed that the filter was not fully injected.Also if a part was not fully molded, then there are no sharp edges, as the edges would be rounded due to the viscosity of the material.As a resolution the customer discarded the defective filter and used different ones from the stock.Further investigation is not possible due to the fact that the filter was discarded by the customer.The risk evaluation results in a risk acceptance level of a medium acceptable health risk.
Event or Problem Description
The customer reported that the microgard filter has sharp edges.There was no patient involvement reported since the event occurred during an incoming inspection.

• Brand Name: MICROGARD IIB
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg ; GM
• Manufacturer (Section G): RIENSCH & HELD GMBH & CO. KG; hans-duncker-str. 1; hamburg 21035 ; GM 21035
• Manufacturer Contact: jared cardon ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 21856584
• Report Number: 9615102-2025-00170
• Device Sequence Number: 20808012
• Product Code: CAH
• UDI-Device Identifier: 14250892903115
• UDI-Public: (01)14250892903115
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MICROGARD IIB
• Device Catalogue Number: V-892380
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown