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

Catalog Number	5-10116
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
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.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.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 "staff has reported that the balloons have failed after intubation, requiring re-intubation with new et tubes.In one case, this occurred twice with the same patient, and in another case, it occurred once." additional information received on april 14, 2026, indicated that "two et tubes were involved, and a total of two patients were involved.The defect was noticed immediately after intubation.No harm to the patient, but medical intervention was required; a bougie was used to re-intubate.The current condition of the patients is stable.Devices were pre-tested per the ifu." associated mdrs: 3003898360-2026-00219.

• Brand Name: SHERIDAN/CF 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25119504
• Report Number: 3003898360-2026-00218
• Device Sequence Number: 21494267
• Product Code: BTR
• UDI-Device Identifier: 04026704396825
• UDI-Public: (01)04026704396825(11)250530(17)300529(10)73E2501071(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 5-10116
• Device Lot Number: 73E2501071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2025
• 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