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

Catalog Number 100/810/080CZ

Device Problem Leak/Splash (1354)

Patient Problem Respiratory Insufficiency (4462)

Event Date 11/25/2023

Event Type  malfunction  

Manufacturer Narrative

H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device had an air bag leakage and resulted in an insufficient inspiratory tidal volume.The tracheostomy cannula was then replaced in a timely manner.The event occurred during patient use.

Manufacturer Narrative

H 6 - evaluation codes: updated.Device evaluation: no device was received for investigation.Therefore, icu medical cannot confirm the reported complaint.If we receive the product we will reopen the investigation.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 product.

Manufacturer Narrative

Udi related data quality updates only.

• Brand Name: PORTEX
• 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: 18422137
• MDR Text Key: 331718200
• Report Number: 3011237704-2023-00018
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315103681
• UDI-Public: (01)15019315103681(11)220919(17)270822(10)4283742
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2024

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 Catalogue Number: 100/810/080CZ
• Device Lot Number: 4283742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/05/2024; 07/25/2024
• Supplement Dates FDA Received: 02/15/2024; 08/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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