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

Model Number IPN048995

Device Problem Break (1069)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

Reported issue: after intubation, when the clinician was trying to connect with y connector, it broke.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

Manufacturer Narrative

(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.A device history record review was performed and no relevant findings were identified.The reported complaint was 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 non-conformance on 08jan2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.

Event Description

Reported issue: after intubation, when the clinician was trying to connect with y connector, it broke.A new device was used without issue.The condition of the patient is reported as "fine".

• Brand Name: HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16616183
• MDR Text Key: 312044672
• Report Number: 3003898360-2023-00411
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 14026704617392
• UDI-Public: 14026704617392
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048995
• Device Catalogue Number: 5-16035
• Device Lot Number: 73F2100315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• 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: NONE REPORTED; NONE REPORTED