MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN/CF ET TUBE,CF,7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10115
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "a patient in the intensive care unit (icu) underwent oral tracheal intubation and was connected to a ventilator at 09:54 on (b)(6) 2025, as per the doctor's orders.At 19:00 on (b)(6), the nurse noticed that the cuff pressure of the tracheal tube was too low and there was an abnormal sound.After re-inflating it, the cuff pressure still could not be maintained at a normal level.The doctor was immediately assisted in replacing the tracheal tube.After the replacement, the patient's vital signs were stable, and the cuff pressure was 27 cmh2o.".
Event or Problem Description
It was reported that: "a patient in the intensive care unit (icu) underwent oral tracheal intubation and was connected to a ventilator at 09:54 on (b)(6) 2025, as per the doctor's orders.At 19:00 on (b)(6), the nurse noticed that the cuff pressure of the tracheal tube was too low and there was an abnormal sound.After re-inflating it, the cuff pressure still could not be maintained at a normal level.The doctor was immediately assisted in replacing the tracheal tube.After the replacement, the patient's vital signs were stable, and the cuff pressure was 27 cmh2o.".
Additional Manufacturer Narrative
Qn# (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.

• Brand Name: SHERIDAN/CF ET TUBE,CF,7.5
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23013887
• Report Number: 3003898360-2025-00677
• Device Sequence Number: 10038254
• Product Code: BTR
• UDI-Device Identifier: 04026704396818
• UDI-Public: (01)04026704396818(11)231026(17)281024(10)73K2300903(21)
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 5-10115
• Device Lot Number: 73K2300903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• 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