MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS #9 ORAL AIRWAY (YELLOW CAP); CONNECTOR, AIRWAY (EXTENSION)

Lot Number 0001199122

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Aspiration/Inhalation (1725); Foreign Body In Patient (2687)

Event Date 01/24/2019

Event Type  Injury  

Event Description

Upon extubation, an oral airway was placed.Simultaneously, the crna noted a loose piece of plastic at the top of the airway.When the crna attempted to remove the loose piece of plastic, the patient inhaled and sucked the piece of plastic to the back of her throat.The crna was able to remove the piece of plastic to prevent aspiration.

• Brand Name: VITAL SIGNS #9 ORAL AIRWAY (YELLOW CAP)
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; mettawa IL 60045
• MDR Report Key: 8292860
• MDR Text Key: 134968163
• Report Number: MW5083544
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0001199122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR