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

Model Number	IPN048995
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: y connector was broken when initially opened.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.The device history review for et tube, sher-i-bronch, ls, 35 fr lot# 73a1900724.Investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: y connector was broken when initially opened.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-16035 et tube, sher-i-bronch, ls, 35 fr for investigation.The y connector and both swivel connectors were returned.The et tube and suction catheters were not returned.The returned connectors were visually examined with and without magnification.Visual examination of the returned samples revealed that the bronchial swivel connector was broken on the 15mm side.The device history review for the et tube, sher-i-bronch, ls, 35 fr lot# 73a1900724 investigation did not show issues related to the complaint.The reported complaint of broken/cracked - double swivel connector is confirmed based on the sample received.The bronchial swivel connector was broken on the 15mm side.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 nc on (b)(6) 2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16329107
• Report Number: 3003898360-2023-00210
• Device Sequence Number: 8813593
• Product Code: CBI
• UDI-Device Identifier: 14026704617392
• UDI-Public: 14026704617392
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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 Model Number: IPN048995
• Device Catalogue Number: 5-16035
• Device Lot Number: 73A1900724
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown