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

Catalog Number 5-16037

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

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 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.

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 (b)(6) 2022 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 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 (b)(4) and 1 patient." no patient involvement.See associated mdrs #3003898360-2023-01511, 3003898360-2 023-01503.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 37 FR
• Type of Device: 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18103619
• MDR Text Key: 328755006
• Report Number: 3003898360-2023-01510
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 04026704397617
• UDI-Public: 04026704397617
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K180253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.