MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN048996
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device history review for the et tube, sher-i-bronch, ls, 37 fr lot# 73g2000058 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: the doctor found the connector broken when using it on a patient.It was changed to a new one; no impact on the patient.
Event or Problem Description
Reported issue: the doctor found the connector broken when using it on a patient.It was changed to a new one; no impact on the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.The y connector and both swivel connectors were returned out of their original packaging.The et tube and two suction catheters were returned in their original packaging.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 the 15mm side.A device history record review was performed and no relevant findings were identified.The complaint has been confirmed.The swivel connector is a component purchased from a supplier.A non-conformance was previously opened to further investigate this issue.Corrective actions were implemented under the non-conformance on 08jan2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.

• Brand Name: HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16567460
• Report Number: 3003898360-2023-00463
• Device Sequence Number: 5498102
• Product Code: CBI
• UDI-Device Identifier: 14026704617408
• UDI-Public: 14026704617408
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 07/05/2025
• Device Model Number: IPN048996
• Device Catalogue Number: 5-16037
• Device Lot Number: 73G2000058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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; NONE REPORTED
• Patient Sex: Unknown