MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE

Model Number 100/541/080CZ

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

It was reported that a patient experienced discomfort after trach tube was inserted.Concerns on which size inner cannula is needed.No adverse patient effects were reported.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 11580284
• MDR Text Key: 242671607
• Report Number: 3012307300-2021-02570
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (y/n): N
• PMA/PMN Number: K060945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/541/080CZ
• Device Catalogue Number: 100/541/080CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1