MAUDE Adverse Event Report: 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
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 # 5-10113 reported is not being manufactured currently, however, another part number from the same family (part # 00001-17, lot # 3141433) was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: (b)(4) samples were taken from the current production; the samples were visually inspected and issue reported "leak - device leak - cuff" 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 that "incident happened on (b)(6) 2021 in the orthopedic-trauma surgery unit.After orotracheal intubation of the patient, the cuff had to be re-inflated several times due to regular pressure leaks.It was monitored with a manometer.This incident caused an increase in ventilatory volumes and of the fio2.The patient desaturation during this procedure".It was reported that the patient had to be reintubated.Patient condition reported as "fine".

• Brand Name: HUDSON ET TUBE,CF,6.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 12738204
• Report Number: 3003898360-2021-00988
• Device Sequence Number: 4099150
• Product Code: BTR
• UDI-Device Identifier: 04026704396795
• UDI-Public: 04026704396795
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: IPN044729
• Device Catalogue Number: 5-10113
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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