Medical Device Alert: Shiley cuffed tracheostomy tubes manufactured by Covidien (formerly Tyco Healthcare) (MDA/2010/032)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/032 or 2009/009/023/401/009.

Technical aspects
Graham Nash or Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3125 / 3219
Fax: 020 7084 3209

Email: graham.nash@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel:  020 7084 3128
Fax: 020 7084 3111 

Email: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.

Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk  

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk 

Slow cuff deflation, which can result in aspiration or inadequate ventilation.

Covidien is recalling affected devices.

Shiley cuffed tracheostomy tubes are intended to be used for up to 29 days for patients with upper airway obstructions, or who need long term ventilation.

There has recently been an increase in the number of failures involving cuff deflation within the first few days after insertion.

The failures appear to be due to very small holes in the pilot balloon, which are not apparent during pre-use checks, leading to gradual deflation.

• Identify all affected Shiley cuffed tracheostomy tubes. Affected lot numbers are listed in the manufacturer’s Field Safety Notice (FSN)
• do not use affected devices, and contact Covidien (020 3027 1757) to arrange replacement
• refer to the manufacturer’s FSN for advice regarding affected devices which are already in use.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (chief executives)
• NHS boards and trusts in Wales (chief executives)
• Primary care trusts in England (chief executives)
• Social services in England (directors)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Adult intensive care units
• All departments
• All wards
• Anaesthetists
• Clinical governance leads
• ENT departments
• General surgeons
• Intensive care, directors of
• Medical directors
• Nursing executive directors
• Paediatric intensive care units
• Risk managers
• Special care baby units
• Supplies departments
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Care homes providing nursing care (adults)
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Nursing agencies
• Private medical practitioners

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Community nurses
• District nurses
• General practitioners

Social services to:
Liaison officers for onward distribution to all relevant staff including:

• In-house residential care homes

Robbie Blackwood
Regional Sales Director
Covidien (UK) Commercial Ltd
154 Fareham Road
Gosport
Hampshire
PO13 0AS

Tel: 07966 117811

Email: robbie.blackwood@covidien.com

If you have any comments or feedback on this Medical Device Alert, please email us on: dts@mhra.gsi.gov.uk