MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,HVT,8.0,NOVA PLUS; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN046760
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/25/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported "the cuff on this tube blew as soon as the patient was intubated, unable to keep air in the cuff immediately after intubation".It was reported that the patient was deceased.It was reported that the device was not contributory to the patient death.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the cuff on this tube blew as soon as the patient was intubated, unable to keep air in the cuff immediately after intubation".It was reported that the patient was deceased.It was reported that the device was not contributory to the patient death.
Additional Manufacturer Narrative
Qn# (b)(4).Corrected data: section h.10.- it was reported in the initial mdr that a device history record (dhr) review could not be conducted; however, a lot number was provided by the customer (lot#73k1900723) when the complaint was initially reported.A dhr review was performed on that lot number and no relevant findings were identified.

• Brand Name: HUDSON ET TUBE,HVT,8.0,NOVA PLUS
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12868298
• Report Number: 3003898360-2021-01044
• Device Sequence Number: 5941834
• Product Code: BTR
• UDI-Device Identifier: 04026704588794
• UDI-Public: 04026704588794
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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 Expiration Date: 10/28/2024
• Device Model Number: IPN046760
• Device Catalogue Number: V5-10316
• Device Lot Number: 73K1900723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention; Death
• Patient Sex: Unknown