MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number AIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES

Device Problem Break (1069)

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

Event Date 10/06/2021

Event Type  Injury  

Event Description

The customer reported that the nurse was repositioning the patient and adjusted the airlife neo-verso y adapter on endotracheal tube and a piece of plastic broke off into her hand.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12973067
• MDR Text Key: 285705352
• Report Number: 3006897516-2021-00003
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES
• Device Catalogue Number: CSC300
• Device Lot Number: 2007020001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 DA
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Race: Black Or African American