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

Model Number VITAL SIGNS¿ ORAL AIRWAY

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.

Event 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.

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
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10608514
• MDR Text Key: 209249523
• Report Number: 8030673-2020-00121
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 10190752131620
• UDI-Public: (01)10190752131620
• Combination Product (y/n): Y
• 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: 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
• Device Operator: 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 Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention