Medical Device Alert: Prelude Short Sheath Introducer manufactured by Merit Medical (MDA/2009/039)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/039 or 2009/004/024/051/002.

Technical aspects
Nicola Grainger or Geoff Ali
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3265 / 3102
Fax: 020 7084 3209

E-mail: nicola.grainger@mhra.gsi.gov.uk or geoff.ali@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

E-mail: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

E-mail: NIAIC@dhsspsni.gov.uk

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic
Further information about SABS can be found at https://sabs.dhsspsni.gov.uk

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

E-mail: iric.nss@nhs.net

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

E-mail: Haz-Aic@wales.gsi.gov.uk

• Check stock for affected devices, stop using and quarantine any devices
• Contact the manufacturer/supplier to arrange for their return.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (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:

• Anaesthetists
• Cardiologists
• Haemodialysis nurses
• Haemodialysis units
• Intensive care medical staff/paediatrics
• Intensive care nursing staff (adult)
• Intensive care nursing staff (paediatric)
• Intensive care units
• Intensive care, directors of
• Paediatric intensive care units
• Paediatric medicine, directors of
• Paediatric nurse specialists
• Paediatric wards
• Paediatricians
• Renal medicine departments
• Renal medicine, directors of
• Staff supporting patients receiving haemodialysis at home
• Supplies managers
• Theatre managers
• Theatre nurses
• Theatres

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Hospitals in the independent sector

Change of address or removal from address list for Care Quality Commission:
National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61
E-mail: enquiries@cqc.org.uk

Marion Robson
Merit Medical EMEA
Amerikalaan 42
6199 AE Maastricht - Airport

Tel: +31 (0) 43 358 8222
Fax: +31 (0) 43 358 8221

E-mail: mrobson@merit.com