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

Catalog Number	5-16037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the doctor found connector broken when doing clinical setting before using on patient.Then changed new one, no impact on patient.Involved 3 pcs and 1 patient." no patient involvement.See associated mdrs #3003898360-2023-01511, 3003898360-2 023-01503.
Additional Manufacturer Narrative
(b)(4).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 device history record review was performed, and no relevant findings were identified.An investigation was previously opened to further investigate this issue.Corrective actions were implemented under the investigation on 15apr2022 to prevent this issue from recurring.The returned sample was manufactured prior to the corrective actions.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the doctor found connector broken when doing clinical setting before using on patient.Then changed new one, no impact on patient.Involved 3 pcs and 1 patient." no patient involvement.See associated mdrs #3003898360-2023-01511, 3003898360-2 023-01503.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found connector broken when doing clinical setting before using on patient.Then changed new one, no impact on patient.Involved 3 pcs and 1 patient." no patient involvement.Associated mdrs #3003898360-2023-01511, 3003898360-2 023-01503.

• Brand Name: SHERIDAN 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18103619
• Report Number: 3003898360-2023-01510
• Device Sequence Number: 5697905
• Product Code: CBI
• UDI-Device Identifier: 04026704397617
• UDI-Public: (01)04026704397617(11)200706(17)250705(10)73G2000058(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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 Catalogue Number: 5-16037
• Device Lot Number: 73G2000058
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 12/12/2023; Not provided
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/13/2023; 07/26/2024
• 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
• Patient Sex: Unknown