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

Model Number	IPN926927
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found connector broken when using on patient.Then changed new one, no impact on patient".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the doctor found connector broken when using on patient.Then changed new one, no impact on patient".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "tube kinked" was confirmed based upon the sample received.The customer returned one unit 5-12516 et tube, cuffed oral, spiral-flex 8.0 for investigation.Visual examination of the returned et tube revealed that the tube was kinked near the proximal end of the tube, near the 26 cm marking and the i.D.8.0 marking.The tube was returned with the bite block on the device.The bite block did not cover the entire length of the kink in the tube.No other defects or anomalies were observed.A functional kink resistance test was performed on the returned et tube per iso test method to determine resistance.The returned et tube was pre-conditioned in a water bath at 40 c for 6 hours.The returned 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% (6.0mm) of the designated size of the et tube is used to check the potency of the lumen.A ball bearing of 6.00mm was used for the kink test.The ball bearing could not pass freely through the tube.Resistance was met at approximately the i.D.8.0 marker.This is the location that is kinked on the tube.The ball was sent through the tube on the opposite end and, once again, could not pass freely through the tube.The ifu for this product states "if a reinforced tube is used orally, a bite block is recommended." a device history record review was performed on the spiral-flex et tube with no evidence to suggest a manufacturing related cause.No further action was required at the time of this report as the damage observed on the et tube is consistent damage that can be caused by pinching the tube with high force.The damage is located at approximately the point at which a patient's mouth would be during use.Although a bite block was used, it does not completely prevent the tube from kinking if force is applied to the tube where the bite block is not seated.Therefore, based on the location and the type of damage observed, unintentional user error caused or contributed to this event.Other remarks: n/a.Corrected data: n/a.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17089859
• Report Number: 3003898360-2023-00934
• Device Sequence Number: 6069760
• Product Code: BTR
• UDI-Device Identifier: 14026704759153
• UDI-Public: 14026704759153
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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 Expiration Date: 09/07/2026
• Device Model Number: IPN926927
• Device Catalogue Number: 5-12516
• Device Lot Number: 73J2100219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown