MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,5.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10111
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).Udi# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "[patient] intubated at northern beaches hospital & transferred to (b)(6) hospital cicu.In cicu there was difficulty oxygenating the patient.Decision made to reintubate patient.When ett was removed a visible kink in tube obstructing the airway".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
(b)(4).Section h.1.-type of reportable event changed to 'serious injury' based on additional information received.Additional information received 10jul2024 indicates "the patient did have desaturations and needed increased fio2 and increasing ventilator pressures as tidal volumes were decreasing progressively.Adding inability to pass a suction catheter, even small suction catheters, through the ett.Prompting the examination and finding the kinked ett which after tube exchange ventilator settings improved." additional information was requested regarding current condition of patient; however, nothing was received at the time of this report.The actual device was not returned; however, the customer provided a photo for evaluation.Based on review of the photo, the complaint was confirmed.Without the actual device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "[patient] intubated at northern beaches hospital & transferred to sydney childrens hospital cicu.In cicu there was difficulty oxygenating the patient.Decision made to reintubate patient.When ett was removed a visible kink in tube obstructing the airway".

• Brand Name: HUDSON ET TUBE,CF,5.5
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19624639
• Report Number: 3003898360-2024-00767
• Device Sequence Number: 6282526
• Product Code: BTR
• UDI-Device Identifier: 04026704396771
• UDI-Public: (01)04026704396771(11)230516(17)280515(10)73E2300581(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: Health Professional
• Device Catalogue Number: 5-10111
• Device Lot Number: 73E2300581
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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
• Patient Sex: Unknown