MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, SHER-I-BRONCH, LS, 28 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Catalog Number	5-16028
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(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.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that: "(b)(6) 2024, after the patient's tracheal intubation went smoothly, the oxygen saturation suddenly dropped to 86% halfway through the surgery, oxygen concentration, oxygen flow, tidal volume were immediately adjusted, and oxygen saturation was restored to 100% after sputum suctioning.The reason for this was found to be a crack at the interface of the double-lumen tube after the surgery was completed." the patient was reported as fine post the procedure with no harm or consequence.
Event or Problem Description
It was reported that: "(b)(6) 2024, after the patient's tracheal intubation went smoothly, the oxygen saturation suddenly dropped to 86% halfway through the surgery, oxygen concentration, oxygen flow, tidal volume were immediately adjusted, and oxygen saturation was restored to 100% after sputum suctioning.The reason for this was found to be a crack at the interface of the double-lumen tube after the surgery was completed." the patient was reported as fine post the procedure with no harm or consequence.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-16028 et tube, sher-i-bronch, ls, 28 fr for investigation.The connector assembly set (tracheal swivel connector, bronchial swivel connector, and y connector) was returned out of its original packaging.The et tube and two suction catheters that come in the et tube kit were not returned.The returned connectors were visually examined with and without magnification.Visual examination of the returned samples revealed that the tracheal swivel connector was broken on both the 15mm side and the 22mm side.The bronchial connector was intact.The swivel connector is a component purchased from a supplier.Corrective and preventive action was previously opened to further investigate this issue.Corrective actions were implemented to prevent this issue from recurring.The returned sample was manufactured prior to the corrective actions.Device history record investigation did not show issues related to complaint.The reported complaint of "broken/cracked - double swivel connector" is confirmed based on the sample received.The tracheal swivel connector was broken on both the 15mm side and the 22mm side.The swivel connector is a component purchased from a supplier.Capa was previously opened to further investigate this issue.Corrective actions were implemented to prevent this issue from recurring.The returned sample was manufactured prior to the corrective actions.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 28 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20694774
• Report Number: 3003898360-2024-01427
• Device Sequence Number: 11707881
• Product Code: CBI
• UDI-Device Identifier: 04026704397594
• UDI-Public: (01)04026704397594(11)210920(17)260919(10)73J2100293(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Expiration Date: 09/19/2026
• Device Catalogue Number: 5-16028
• Device Lot Number: 73J2100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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