MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 100/800/075

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that after insertion, the ventilator is found to indicate low tidal volume due to air bag leakage.The air cut kit was replaced.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

No product was returned for investigation so no visual or functional testing could be performed; however due to fact that cuff leak was discovered during use (not before tracheostomy procedure by pretesting) it is most probable that the reported failure occurred due to contact with sharp.Without the sample the manufacturer is unable to determine true root cause of the issue.A review of the device history records (dhr) shows there were no observations recorded during manufacturing of the reported lot number.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 16624592
• MDR Text Key: 312252268
• Report Number: 3012307300-2023-03060
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/800/075
• Device Catalogue Number: 100/800/075CZ
• Device Lot Number: 4106730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male