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

Catalog Number	5-10315
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the reported defect of "unable to inflate - cuff" was confirmed upon investigation of the returned sample.The customer returned one unit 5-10315 et tube, hvt, 7.5 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appeared typical.No defects or anomalies were observed.Functional inspection showed that upon inflation, the device leaked from a hole in the balloon cuff.A review of the manufacturing process confirmed that tracheal tubes undergo 100% inspection, inflation and deflation test as part of the product release criteria.Any obvious defects as per returned sample that do not meet the quality assurance specification should have been detected and rejected, as they would fail all tests at the manufacturing site.Therefore, this defect could not be attributed to manufacturing issues.Additionally, a device history record was conducted and no issue related to complaint was noted.The device was manufactured according to release specification.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "patient reintubated, when ett in place, air was pushed into the cuff but the cuff did not inflate.Ett had to be replaced.There no reported patient harm or consequence.".

• Brand Name: SHERIDAN ET TUBE, HVT, 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22468411
• Report Number: 3003898360-2025-00561
• Device Sequence Number: 4149301
• Product Code: BTR
• UDI-Device Identifier: 04026704397044
• UDI-Public: (01)04026704397044(11)250113(17)300112(10)73A2500250(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 06/24/2025

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: 5-10315
• Device Lot Number: 73A2500250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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: NOT REPORTED
• Patient Sex: Unknown