Medical Device Alert: Visionary single-use laryngeal airway device manufactured by Marshall Products Ltd (MDA/2010/041)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/041 or 2010/003/026/081/016.

Technical aspects
Douglas McIvor or Yasser Zayni
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3193 / 3238
Fax: 020 7084 3209

Email: douglas.mcivor@mhra.gsi.gov.uk or yasser.zayni@mhra.gsi.gov.uk

Clinical aspects
Tom Clutton-Brock
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3056
Fax: 020 7084 3111

Email: tom.clutton-brock@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

There is the potential for the LAD connector to break when attached to other devices. This can cause patient ventilation to be interrupted until the airway is replaced.

The manufacturer initiated a product recall through a Field Safety Notice in April 2010 listing affected product codes and lot numbers.

• Identify and quarantine devices from affected lots.
• Return affected lots to the manufacturer for replacement.

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)

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:

• A&E departments
• All wards
• Ambulance staff
• Anaesthetic nursing staff
• Anaesthetists
• Day surgery units
• High dependency units
• Intensive care units
• Maternity units
• Medical directors
• Midwifery departments
• Nursing executive directors
• Operating department practitioners
• Paediatric intensive care units
• Paediatric outpatients
• Paediatric wards
• Paramedics
• Resuscitation officers and trainers
• Risk managers
• Special care baby units
• Supplies departments 
• Theatre managers
• Theatres

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

• Hospitals in the independent sector
• Independent treatment centres

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

• Resuscitation officers

Alison Easto
Marshall Products Ltd

Tel: 0845 612 8888

Email: alison@marshallproducts.co.uk