MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN ET TUBE, CUFFED, SPIRAL-FLEX 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12614
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Airway Obstruction (1699); Low Oxygen Saturation (2477)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2025, an anesthesiologist placed a tube for a patient with prostate cancer.Approximately two hours into the surgery, the patient's airway pressure increased.Upon examination, it was found that the inner membrane of the tube had bulged, almost completely obstructing the tube.We have not received any reports of patient harm from this incident.It occurred near the end of surgery, when a sudden rise in airway pressure led the anesthesiologist to suspect an asthma attack and initiate emergency procedures.Fortunately, the issue was identified promptly, and the patient did not experience prolonged low oxygen saturation.The patient's pacu observation was longer than for similar surgeries to ensure no additional injuries after full awakening.Fortunately, recovery was unaffected.Oxygen saturation briefly dropped below 95%, but due to prompt detection, prolonged hypoxemia did not occur.The anesthesiologist had tested the tube integrity and cuff for leaks before use.".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "tube kinked" was confirmed based upon the investigation of the sample received.The customer provided one photo and returned one unit 5-12614 et tube, cuffed, spiral-flex 7.0 for investigation.Visual and functional inspection of the returned sample revealed that the tube was kinked at the distal end of the connector.The inner part of the tube was occluded due to the kink.A device history record review was performed on the spiral-flex et tube with no evidence to suggest a manufacturing related cause.The damage observed on the et tube is consistent with damage that can be caused by pinching the tube with high force.It could not be determined what caused the tube to kink, but it could have been caused by the positioning of the patient and/or the patient biting the tube.Based on the type of damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "(b)(6) 2025, an anesthesiologist placed a tube for a patient with prostate cancer.Approximately two hours into the surgery, the patient's airway pressure increased.Upon examination, it was found that the inner membrane of the tube had bulged, almost completely obstructing the tube.We have not received any reports of patient harm from this incident.It occurred near the end of surgery, when a sudden rise in airway pressure led the anesthesiologist to suspect an asthma attack and initiate emergency procedures.Fortunately, the issue was identified promptly , and the patient did not experience prolonged low oxygen saturation.The patient's pacu observation was longer than for similar surgeries to ensure no additional injuries after full awakening.Fortunately , recovery was unaffected.Oxygen saturation briefly dropped below 95%, but due to prompt detection, prolonged hypoxemia did not occur.The anesthesiologist had tested the tube integrity and cuff for leaks before use.".

• Brand Name: SHERIDAN ET TUBE, CUFFED, SPIRAL-FLEX 7.0
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24092794
• Report Number: 3003898360-2026-00039
• Device Sequence Number: 10238877
• Product Code: BTR
• UDI-Device Identifier: 04026704397402
• UDI-Public: (01)04026704397402(11)250130(17)300129(10)73A2501037(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K844296
• 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): 12/25/2025

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: 5-12614
• Device Lot Number: 73A2501037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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.; NOT REPORTED.
• Patient Sex: Unknown