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

Model Number V-892381

Device Problem Sharp Edges (4013)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2019

Event Type  malfunction  

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 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
• Type of Device: FILTER, BACTERIAL, BREATHING CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL GERMANY 234 GMBH; leibnizstrasse 7; hochberg, 97204 ; GM 97204
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8676573
• MDR Text Key: 147315160
• Report Number: 9615102-2019-00105
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 34250892903034
• UDI-Public: (01)34250892903034(11)153948-48
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K111408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/17/2019
• 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: Unknown
• Patient Sequence Number: 1