MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ ORAL AIRWAY; AIRWAY ACCESS

Catalog Number 3590

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to vyaire via a medwatch report that upon extubation, an oral airway was placed, simultaneously, the clinician noted a loose piece of plastic at the top of the airway.When the clinician attempted remove the loose piece of plastic, the patient inhaled and sucked the piece of plastic to the back of her throat.The clinician was able to remove the piece of plastic to prevent aspiration.The customer confirmed that there was no patient injury associated with the reported issue.

Manufacturer Narrative

Code 81 other-vyaire medical's quality investigation team concludes that according to the investigation, the suspect device is provided by an external vendor and the loose plastic is a flash of the product.It is considered that the flash was not removed during the manufacturing of this product at the supplier's facility.Scar 2019000014 was initiated.

• Brand Name: VITAL SIGNS¿ ORAL AIRWAY
• Type of Device: AIRWAY ACCESS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8398940
• MDR Text Key: 139569491
• Report Number: 8030673-2019-00031
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3590
• Device Lot Number: 0001199122
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention