MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. REDITUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	8070RTC
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During case, ett (endotracheal tube) collapsed and anesthesia was unable to ventilate patient.

• Brand Name: REDITUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 510 technology dr.; irvine CA 92618
• MDR Report Key: 20343188
• Report Number: 20343188
• Device Sequence Number: 20794042
• Product Code: BTR
• UDI-Device Identifier: 10190752148758
• UDI-Public: (01)10190752148758(10)24D105603K(11)240401(17)290301
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2024
• Report Date (Section F): 09/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8070RTC
• Device Catalogue Number: 8070RTC
• Device Lot Number: 24D105603K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 09/09/2024