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

Catalog Number	5-10115
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - cuff" was confirmed based upon the sample received.The returned et tube was found to have a hole in the balloon cuff which prevented it from being able to stay inflated.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "ett cuff would not hold pressure after placement.Sometimes the leak was obvious (cuff deflated quickly), while other times it was a slow leak over time.In all of these cases, the patient ultimately required an ett exchange.The cuffs are routinely tested before intubation and appear to be functioning properly at the time of placement, but it's difficult to identify a slow leak in the moments prior to intubation.Over the past 9 months, there have been 6 incidents where a tube had a slow leak while in the patient.In one incident, the tube completely burst and failed.There was patient involvement and no harm." two issues reported (cuff leak and burst).Associated mdrs: 3003898360-2026-00290.Additional information received on june 16, 2026, indicated that there were no reports of patient harm or adverse health consequences.However, patients required reintubation in the reported events.No information is available regarding the individual patients' current condition.The time the tubes remained in place before the issue was detected varied from minutes to hours.Some patients experienced desaturation, with varying degrees of severity.The devices were tested prior to use.

• Brand Name: SHERIDAN 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25727770
• Report Number: 3003898360-2026-00291
• Device Sequence Number: 10459539
• Product Code: BTR
• UDI-Device Identifier: 04026704396818
• UDI-Public: (01)04026704396818(11)260114(17)310113(10)73A2600266(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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 5-10115
• Device Lot Number: 73A2600266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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.
• Patient Sex: Unknown