MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX TUBES BLUSELECT SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/860/080

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

Patient Problem Insufficient Information (4580)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

H3 other: device has not been returned.Device evaluation: no product was received for investigation.Therefore, we are unable to confirm the reported complaint.If we receive the device, we will reopen the investigation for further evaluation.Due to fact that 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 instruction for use.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

Event Description

It was reported that the tracheostomy tube and accessories have expired, its components must be replaced.Before replacement, it has been tested to be normal and there was no obvious air leakage.But the air bag is not inflated well after the replacement, the reason is unknown.The patient had to be re-intubated.There was patient involvement, with harm/adverse effect reported.Details about the patient harm were not provided.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18962094
• MDR Text Key: 338432505
• Report Number: 3011237704-2024-00071
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315104725
• UDI-Public: (01)15019315104725(17)270718(10)4283691
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/860/080
• Device Catalogue Number: 100/860/080CZ
• Device Lot Number: 4283691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Male