Medical Device Alert: Peripheral cannula, Nexiva closed IV catheter system with Q-Syte connector, manufactured by Becton Dickinson (MDA/2010/017)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/017 or 2010/002/010/081/015.

Technical aspects
Nicole Small or Sharon Knight
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3310/3203
Fax: 020 7084 3209

Email: nicole.small@mhra.gsi.gov.uk or sharon.knight@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

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).

The NHS Supply Chain code in the Device section does not apply.

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 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).

The NHS Supply Chain code in the Device section does not apply.

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).

The NHS Supply Chain code in the Device section does not apply.

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

The manufacturer has received reports of air entering into infusion lines through the BD Q-Syte connector.

Risk of air embolus to patients.

This problem is an extension of the original action detailed in MDA/2009/075 - Needle-free intravascular connectors manufactured by Becton Dickinson.

Becton Dickinson issued a Field Safety Notice to customers on 2 November 2009 to withdraw certain lot numbers of the Q-Syte needle-free connector due to the risk of air embolism and this was supported by MDA/2009/075.

The manufacturer has extended the original action to include certain lot numbers of the Nexiva peripheral cannula, which include Q-Syte connectors that may be affected by this problem, and issued a Field Safety Notice to customers on 12 February 2010. The MHRA has issued this Medical Device Alert to ensure that users are aware of this problem.

• Quarantine and do not use devices from affected lot numbers.
• Contact Becton Dickinson to arrange for credit or replacement product.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Health Protection Agency (HPA) (Directors)
• 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:

• Accident and emergency departments
• All clinical departments
• All wards
• Anaesthetists
• Clinical governance leads
• Day surgery units
• Hospital at home units
• Infection control nurses
• Intensive care units (adult and paediatric)
• IV nurse specialists
• Medical directors
• Nursing executive directors
• Outpatient clinics
• Outpatient theatre managers
• Palliative care teams
• Paramedics
• Phlebotomists
• Purchasing managers
• Risk managers
• Supplies managers
• Theatre managers

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

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

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

• Community children’s nurses
• Community hospitals
• Community nurses
• District nurses
• Infection control nurses
• Nutritional nurse specialists
• Palliative care team

Becton Dickinson
Customer Services
The Danby Building
Edmund Halley Road
Oxford
OX4 4DQ

Tel: 01865 781 517
Fax: 01865 781 501

Email: val_mummery@europe.bd.com