Medical Device Alert: Intravenous burette administration set manufactured by Codan (MDA/2009/036)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/036 or 2009/003/023/291/013.

Technical aspects
Nicola Ridd or Nicole Small
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3039 / 3310
Fax: 020 7084 3209
E-mail:
nicola.ridd@mhra.gsi.gov.uk
nicole.small@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@shs.csa.scot.nhs.uk

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

The manufacturer has identified the potential for leakage from the drip chamber of certain burette sets. This could result in inadequate intravenous administration.

• Identify devices with batch numbers F74916-1 or F74916-2 and place them into quarantine.
• Contact Codan, who will arrange collection of the product and provide replacement or credit.

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)
• Primary care trusts in England (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
• All clinical departments
• Day surgery units
• IV nurse specialists
• Medical directors
• Nursing executive directors
• Outpatients
• Purchasing managers
• Risk managers
• Supplies managers
• Theatre managers

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

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

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

• Community hospitals
• Community children’s nurses
• District nurses
• Equipment libraries and stores
• Palliative care team

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

Charlie Callaghan
Codan Ltd
Eastheath Avenue
Wokingham RG41 2PR

Tel: 0118 978 3663
Fax: 0118 977 6274

E-mail: cc@codanmed.co.uk