MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS ORAL AIRWAY; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number	VITAL SIGNS¿ ORAL AIRWAY
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.
Event or Problem Description
The customer reported that the small, yellow piece of plastic on 3590 vital signs¿ oral airway slid out of the oral airway into patient's pharynx during intubation.The customer confirmed that it was removed with hagil forceps prior to case start preventing harm to patient.
Additional Manufacturer Narrative
Result of investigation: vyaire medical was able to determined the reported issue.One opened decontaminated sample was received for evaluation.It was observe that part number r3090h2 has excess loose yellow material.The root cause was traced to the material - material does not meet manufacturers specifications.As a corrective and preventive action, existing scar (b)(4) was initiated.

• Brand Name: VITAL SIGNS ORAL AIRWAY
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10608514
• Report Number: 8030673-2020-00121
• Device Sequence Number: 11461462
• Product Code: CAE
• UDI-Device Identifier: 10190752131620
• UDI-Public: (01)10190752131620
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: VITAL SIGNS¿ ORAL AIRWAY
• Device Catalogue Number: 3590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention