MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, HVT, 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048895
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/11/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of the reported failure mode was conducted, and 125 samples were taken from the current production (material number 5-10313 lot # 73c2100906) at the manufacturing facility.The samples were visually inspected, and issue reported "detached - connector" was not observed in the current manufacturing process.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 "endotracheal tube hub disconnect while proning of the patient which caused the patient to quickly desaturate.This was due to the patient's status which was critical due to complications from covid-19.Additionally, due to the endotracheal tube hub disconnect the vent alarms went off and the patient quickly desaturated.An endotracheal tube exchange was performed with the use of a bougie and a video laryngoscope was used for confirmation of the intubation.The patient was in a supine position during the disconnect.The bmi of the patient was 23.9 kg.The peak airway pressure (pap) was 37 cmh20 and the peek and expiratory pressure (peep) was 5.As a result of the patient's critical status and rapid desaturation the patient expired".

• Brand Name: HUDSON ET TUBE, HVT, 7.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11697381
• Report Number: 3003898360-2021-00364
• Device Sequence Number: 14330460
• Product Code: BTR
• UDI-Device Identifier: 14026704616746
• UDI-Public: 14026704616746
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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
• Operator of Device: No Information
• Device Model Number: IPN048895
• Device Catalogue Number: 5-10314
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention