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

Model Number	IPN044732
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 "during use on the patient, ventilation was insufficient.The air did not go into the patient.Patient had to be re-intubated and ventilated by hand.No patient harm occurred".Unknown patient condition at time of report.
Additional Manufacturer Narrative
Qn #(b)(4).The customer returned one unit 5-10116 et tube, cf, 8.0 for investigation.The et tube was received without its original packaging.The returned et tube was visually examined with and without magnification.Visual examination of the returned et tube revealed that the sample appears typical.No visual kinks or other defects were observed.A functional kink resistance test was performed on the returned et tube per iso-5361; 2012 edition, annex h - test method to determine resistance.The returned et tube was pre-conditioned in a water bath at 40 c for 6 hours.Then, the et tube was strapped securely to a kink test fixture to create a radius of curvature of 40mm.A steel ball of a minimum 75% (6mm) of the designated size of the et tube is used to check the potency of the lumen.A ball bearing of 6mm was used for the kink test.Upon testing, the ball bearing was able to pass freely through the tube.Multiple attempts were made from both ends of the tube and no issues were observed.The returned sample was able to pass the kink resistance test.Additionally, the tube was filled with water to test for leaks in the tube.No leaks were detected that could cause issues with proper ventilation.The reported complaint was not confirmed based upon the sample received.The returned et tube was functionally tested for kinking.A ball bearing of a minimum of 75% the size of the inner diameter of the tube was able to freely pass through the tube multiple times with no issues.Additionally, no leaks were detected in the tube.A device history record review was performed with no evidence to suggest a manufacturing related cause.It's possible that the tube was not connected properly, but this could not be determined based on the returned sample.No functional issues were found with the returned device.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "during use on the patient, ventilation was insufficient.The air did not go into the patient.Patient had to be re-intubated and ventilated by hand.No patient harm occurred".Unknown patient condition at time of report.

• Brand Name: HUDSON ET TUBE,CF,8.0
• 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: 12617223
• Report Number: 3003898360-2021-00922
• Device Sequence Number: 16477584
• Product Code: BTR
• UDI-Device Identifier: 14026704616531
• UDI-Public: 14026704616531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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
• Device Expiration Date: 02/12/2024
• Device Model Number: IPN044732
• Device Catalogue Number: 5-10116
• Device Lot Number: 73B1900330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2019
• 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