MAUDE Adverse Event Report: VYAIRE MEDICAL MICROGARD II; FILTER, BACTERIAL, BREATHING CIRCUIT

Model Number	V-892381
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A photo of the shard from the filter was provided by the distributor.The actual shard has been requested, but not yet received for evaluation.No patient was involved, as the shard was found before the filter was placed into use.
Event or Problem Description
Customer reported that a sharp shard was extracted by the laboratory staff from the microgard ii filter before test, in response to a rattling noise in the filter.They kept the sharp shard and there was no apparent breakage of the filter.They threw away the filter, but retained the shard and the plastic product bag.The customer reported no patient involvement associated with the event.

• Brand Name: MICROGARD II
• Common Device Name: FILTER, BACTERIAL, BREATHING CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8676573
• Report Number: 9615102-2019-00105
• Device Sequence Number: 265353
• Product Code: CAH
• UDI-Device Identifier: 34250892903034
• UDI-Public: (01)34250892903034(11)153948-48
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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 Expiration Date: 11/15/2021
• Device Model Number: V-892381
• Device Catalogue Number: V-892381
• Device Lot Number: 153948-48
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1