MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN ET TUBE, HVT, 6.0; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	5-10312
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during a neurosurgery case (vp shunt), the head was flexed momentarily so that the head could be prepped for surgery.After the neck was flexed, the ventilation became impaired.We were unable to effectively ventilate the patient through this ett despite the neck returned to a neutral position.An appropriately sized suction catheter was passed into this ett, and it would not pass completely through.There were no secretions.A flexible bronchoscope was placed and identified a complete narrowing within the ett at a point beyond the patient's vocal cords, somewhere within the trachea.Decision made to extubate the patient and reintubate with another ett.".
Additional Manufacturer Narrative
(b)(4).Failure mode "tube deformed" could be confirmed with picture attached.However it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.If the complaint samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: SHERIDAN ET TUBE, HVT, 6.0
• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25669018
• Report Number: 3003898360-2026-00283
• Device Sequence Number: 21434141
• Product Code: BTR
• UDI-Device Identifier: 14026704941077
• UDI-Public: (01)14026704941077(11)251009(17)301008(10)73K2500360(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: 5-10312
• Device Lot Number: 73K2500360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2025
• 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: NONE REPORTED.
• Patient Sex: Unknown