MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,8.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10117
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: patient was intubated with the 8.5 oral endotracheal tube.When the bronch was started and the scope was to pass through the ett to the lungs, the ett was kinked so badly the scope would not pass.Tried to use a bougie to switch out tubes, but bougie would not pass kinked spot.Had to reintubate patient with another ett from another manufacturer to finish procedure.The reported defect was detected during use on patient.The patient condition was reported as "fine" post-procedure.Medical intervention reported states: ett was removed and patient was reintubated.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "tube deformed" could not be confirmed based upon the samples received.The customer returned five units 5-10117 et tube, cf,8.5 for investigation.Four of the returned samples were representative samples that were in their original packaging.The other sample was returned without its original packaging.The returned et tubes were visually examined with and without magnification.Visual examination of the returned et tube revealed that the samples all appear typical.No visual kinks or other defects were observed with any of the returned devices.A device history record review was performed with no evidence to suggest a manufacturing related cause.Based on the returned samples, this complaint could not be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: patient was intubated with the 8.5 oral endotracheal tube.When the bronch was started and the scope was to pass through the ett to the lungs, the ett was kinked so badly the scope would not pass.Tried to use a bougie to switch out tubes, but bougie would not pass kinked spot.Had to reintubate patient with another ett from another manufacturer to finish procedure.The reported defect was detected during use on patient.The patient condition was reported as "fine" post-procedure.Medical intervention reported states: ett was removed and patient was reintubated.

• Brand Name: ET TUBE,CF,8.5
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18902062
• Report Number: 3003898360-2024-00243
• Device Sequence Number: 7838939
• Product Code: BTR
• UDI-Device Identifier: 04026704396832
• UDI-Public: 04026704396832
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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 Expiration Date: 10/04/2026
• Device Catalogue Number: 5-10117
• Device Lot Number: 73K2100181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown