Medical Device Alert: First Steps medicine feeder manufactured by RSW International Ltd (MDA/2009/045)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/045 or 2009/006/003/301/001

Technical aspects
Ainsley Wickens or Catriona Blake
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 3273/3219
Fax: 020 7084 3209
E-mail: ainsley.wickens@mhra.gsi.gov.uk
catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and 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: nss.iric@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

The medicine feeder has two measurement scales, millilitres (ml) and teaspoons (tsp). Confusion between the scales has led to a serious overdose in a six month old infant who was repeatedly administered 2.5 tsp (~13ml) of medication instead of 2.5ml. The manufacturer has recalled this product.

RSW International Ltd issued the recall notice to its customers (both retail and wholesale) on 12 June 2009. The recall notice does not give details of the risks that the product poses, may not have reached some retail outlets, and will not have reached parents and carers who have already purchased this medicine feeder.

Consequently, the MHRA issued a press release on 16 June 2009 to provide more detailed information and is now targeting this Medical Device Alert at healthcare professionals who may be able to bring this recall to the attention of parents and carers by displaying the MHRA urgent information sheet (see Appendix) in public areas.

Display the MHRA urgent information sheet in public areas where parents and carers of babies and young infants are likely to see it. Help bring this recall to the attention of parents and carers so they stop using the feeders and dispose of them.

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)
• OFSTED (Directors of Children’s Services)
• 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:

• A&E departments
• Clinical governance leads
• Intensive care (paediatric)
• Maternity units
• Medical directors
• Midwifery departments
• Neonatology departments
• Paediatric outpatients
• Paediatric wards
• Paediatricians
• Pharmacists
• Risk managers
• Special care baby units

OFSTED to:
MHRA consider this to be relevant to:

• Children’s services
• Educational establishments with beds for children
• Nurseries
• Ofsted inspectors - early years
• Pre-schools
• Residential special schools

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

• Community children’s nurses
• Community midwives
• Community nurses
• Community pharmacists
• District nurses
• General practitioners
• Health visitors
• Immunisation co-ordinators
• Minor injury units
• NHS walk-in centres
• Pharmaceutical advisors
• Practice managers
• Practice nurses
• School nurses
• Walk-in centres

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

• Children’s services
• Education departments

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

Manufacturer
Richard Richardson
RSW International Ltd
Unit 4
Cowm Top Business Park
Cowm Top Lane
Rochdale
OL11 2PU
Tel: 0845 226 8311
Fax: 0845 226 8322
E-mail: rrichardson@rswint.co.uk