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

Catalog Number	5-10316
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
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 "ccu 1 was initially intubated on (b)(6) at 23:27 with an 8.0 ett.Patient self-extubated on (b)(6) at 00:24 and was reintubated by md and pa with a 2nd 8.0 ett.Md noticed that the balloon was deflating within 30 seconds, and an audible leak was heard.We opened a 7.5 ett, and it was safely exchanged with a bougie after checking patency.The team that was present during both intubations debriefed and confirmed that both etts were checked for patency and cuff integrity prior to placement.Following physical assessment of the 1st and 2nd etts, it was noted that both cuffs exhibited a slow air leak, resulting in gradual cuff deflation." additional information received on june 30, 2026, indicated that "the patient had desaturated 10-20%." two devices involved.Associated mdrs: 3003898360-2026-00304.

• Brand Name: SHERIDAN ET TUBE, HVT, 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: 25814592
• Report Number: 3003898360-2026-00303
• Device Sequence Number: 17658553
• Product Code: BTR
• UDI-Device Identifier: 14026704941114
• UDI-Public: (01)14026704941114(11)260117(17)310116(10)73A2600584(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (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): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5-10316
• Device Lot Number: 73A2600584
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2026
• 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.; NONE REPORTED.
• Patient Sex: Unknown