MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN/CF ET TUBE,CF,6.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10113
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the regular stock item is out so the substitute items that was ordered for size 6.0mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm endotracheal tubes sheridan brand are the wrong cuff type-- we are receiving the low volume/hi pressure cuffed endotracheal tubes rather than the hi volume/low pressure cuff endo tracheal tubes.Patients are waking up post surgery with very sore throats and possible stridor on inspiration with the wrong endotracheal substitute cuffs.There were no reported desaturations.".
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.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: SHERIDAN/CF ET TUBE,CF,6.5
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22356223
• Report Number: 3003898360-2025-00496
• Device Sequence Number: 8705933
• Product Code: BTR
• UDI-Device Identifier: 04026704396795
• UDI-Public: (01)04026704396795(11)241017(17)291016(10)73K2400576(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: 5-10113
• Device Lot Number: 73K2400576
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2024
• 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
• Patient Sex: Unknown