MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/860/075

Device Problems Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2023

Event Type  Injury  

Event Description

It was reported, that at 15:19 on september 16, a tracheotomy was performed by an ent doctor.Before the operation, the suction endotracheal tube was inspected.And its accessories were in good condition and within the validity period in accordance with the specifications.After surgical placement of the suction endotracheal tube and accessories, fixation and inflating, it was found, that the air bag failed to reach the ideal level, after being inflated multiple times."air bag leakage was being considered, as the cause.And the suction tracheostomy tube and accessories should be replaced immediately and repositioned".During this period, the patient's vital signs were stable.

Manufacturer Narrative

G5: 510k is blank, this catalog number is not sold in the united states.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.Due to the fact that the cuff leak was observed after placement it is the most probable that reported failure occurred during tracheostomy procedure due to contact with sharp edge which is in conflict with instructions for use."guard against cuff damage by avoiding contact with sharp edges".Unfortunately, without the sample we are unable to determine the true root cause of this issue.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18007121
• MDR Text Key: 326555725
• Report Number: 3012307300-2023-09895
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/860/075
• Device Catalogue Number: 100/860/075CZ
• Device Lot Number: 4285821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male