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

Model Number	IPN048897
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	05/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Part number reported, 5-10316 et tube, hvt, 8.0, is not being manufactured currently, however, another part number from the same family, material number 00003-15 lot number 3062687, was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 315 samples were taken from the current production, the cuff from the samples were inflated and left for four hours, after this time samples were checked to verify if any leak was present however all samples were still fully inflated, defect reported "leak - device leak - cuff" was not observed in the current manufacturing process.A device history record review was not performed, as the lot number was not provided at time of report.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 "when the tube has to stay in the patient for a while, there is a cuff leakage.Cuff has to be inflated or replaced".No patient injury or consequence reported.Attempts for additional information have been unsuccessful.Patient condition unknown at time of report.

• Brand Name: HUDSON ET TUBE, HVT, 8.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12068081
• Report Number: 3003898360-2021-00558
• Device Sequence Number: 4765054
• Product Code: BTR
• UDI-Device Identifier: 14026704616760
• UDI-Public: 14026704616760
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: No Information
• Device Model Number: IPN048897
• Device Catalogue Number: 5-10316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1