MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,6.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044729
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "incident happened on (b)(6) 2021, in the orthopedic and trauma surgery unit.We faced leaks of the cuff.The consequence was a desaturation of the patient with the risk of acute respiratory distress.This incident necessitated an overpressure at the level of the cuff".Patient condition reported as "fine".
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, 5-10113 et tube,cf,6.5, is not being manufactured currently, however, another part number from the same family (part # 00001-08 lot # 3150326) was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 125 samples were taken from the current production; the samples were visually inspected and issue reported "leak - gas leak - other" 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.

• Brand Name: HUDSON ET TUBE,CF,6.5
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 12800274
• Report Number: 3003898360-2021-01009
• Device Sequence Number: 8551319
• Product Code: BTR
• UDI-Device Identifier: 14026704616500
• UDI-Public: 14026704616500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 07/24/2023
• Device Model Number: IPN044729
• Device Catalogue Number: 5-10113
• Device Lot Number: 73G1800793
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown