MAUDE Adverse Event Report: TELEFLEX MEDICAL DOUBLE LUMEN BRONCHIAL TUBE SET LEFT

Catalog Number 116100370

Device Problem Break (1069)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The report states while in use on a patient, "broken tracheal inflation cuff, so it is necessary to carry out a new orotracheal intubation and change the tube." no patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no complaint sample was returned for analysis.A representative sample was retrieved from production lot for simulation purpose.Visual inspection was conducted on the production representative sample and no obvious defect was observed.As part of functional inspection, the cuff pressure of the production representative sample was then inflated to 25mbar by using calibrated endotesta and no abnormality was observed on the sample.Water leak test was then conducted on the sample.No air bubbles were observed flowing out from both cuffs.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable root cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The report states while in use on a patient, "broken tracheal inflation cuff, so it is necessary to carry out a new orotracheal intubation and change the tube." no patient harm or injury.The patient status is reported as "fine".

• Brand Name: DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• Type of Device: BRONCHIAL TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17599039
• MDR Text Key: 321726963
• Report Number: 8040412-2023-00326
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K141888
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 116100370
• Device Lot Number: KME23A2876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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.
• Patient Age: 35 YR
• Patient Sex: Female