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

Catalog Number 5-16035

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

It was reported that while in use on a patient, "the air leaking was found when the patient had to be turned around, leaking was from the broken y connector".This occurred directly after intubation.The device was tested prior to use.A 'jelly' lubricant was used for intubation.The issue was resolved by changing the tube.No patient harm, desaturation, or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that while in use on a patient, "the air leaking was found when the patient had to be turned around, leaking was from the broken y connector".This occurred directly after intubation.The device was tested prior to use.A 'jelly' lubricant was used for intubation.The issue was resolved by changing the tube.No patient harm, desaturation, or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Additional information received on 28 july 2023 states that the "doctor opened a new y connector to replace the broken one".Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

• Brand Name: 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
• MDR Report Key: 17405545
• MDR Text Key: 320137175
• Report Number: 3003898360-2023-01141
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-16035
• Device Lot Number: 73F2100315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: N/A.; N/A.