MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX DISPOSABLE PERCUTANEOUS TRACHEOSTOMY (PCT); TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number 100/541/080CZ

Device Problems Fluid/Blood Leak (1250); Decrease in Pressure (1490)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 04/15/2022

Event Type  Injury  

Event Description

It was reported that after 15 minutes of use a persistent leak was observed.A test before insertion was carried out and no issue was notified.A loss of pressure was identified.Needed to perform trach change.

Manufacturer Narrative

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.The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

• Brand Name: PORTEX DISPOSABLE PERCUTANEOUS TRACHEOSTOMY (PCT)
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14492335
• MDR Text Key: 292577021
• Report Number: 3012307300-2022-09564
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/541/080CZ
• Device Catalogue Number: 100/541/080CZ
• Device Lot Number: 4217052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1