MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, SHER-I-BRONCH, LS, 35 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Catalog Number	5-16035
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the patient underwent a lung lesion resection surgery in the operating room of our hospital on (b)(6) 2025.During the operation, lung isolation was required.The anesthesiologist used a disposable sterile bronchial tube for bronchial intubation.After following the normal operation procedure, the disposable sterile bronchial tube could not be adjusted within the trachea, resulting in poor alignment of the bronchial tube and the pulmonary bronchus, and thus making it impossible to perform lung isolation ventilation.When inserted into the glottis, it has difficulty rotating.The anesthesiologist then removed the disposable sterile bronchial tube and replaced it with a disposable double-lumen bronchial tube for re-intubation.The lung isolation ventilation was successfully carried out, and the subsequent surgery proceeded normally.The second intubation caused pain to the patient and increased risks.The doctor reported that the texture of this batch of tubes was too soft and unable to support, making it difficult to move during adjustment.There was no other reported patient harm.".
Event or Problem Description
It was reported that: "the patient underwent a lung lesion resection surgery in the operating room of our hospital on (b)(6) 2025.During the operation, lung isolation was required.The anesthesiologist used a disposable sterile bronchial tube for bronchial intubation.After following the normal operation procedure, the disposable sterile bronchial tube could not be adjusted within the trachea, resulting in poor alignment of the bronchial tube and the pulmonary bronchus, and thus making it impossible to perform lung isolation ventilation.When inserted into the glottis, it has difficulty rotating.The anesthesiologist then removed the disposable sterile bronchial tube and replaced it with a disposable double-lumen bronchial tube for re-intubation.The lung isolation ventilation was successfully carried out, and the subsequent surgery proceeded normally.The second intubation caused pain to the patient and increased risks.The doctor reported that the texture of this batch of tubes was too soft and unable to support, making it difficult to move during adjustment.There was no other reported patient harm.".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 13 samples were taken from the current production; the samples were visually inspected, and issue reported "blocked/obstructed - bronchial tubing" was not observed in the current manufacturing process.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.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 35 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• 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: 22794210
• Report Number: 3003898360-2025-00623
• Device Sequence Number: 8771346
• Product Code: CBI
• UDI-Device Identifier: 04026704397600
• UDI-Public: (01)04026704397600(11)240625(17)280531(10)73F2400800(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 5-16035
• Device Lot Number: 73F2400800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2024
• 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; NOT REPORTED
• Patient Sex: Unknown