Needle-free intravenous connectors - incompatibility and risk of infection

NEEDLE-FREE INTRAVENOUS CONNECTORS - INCOMPATIBILITY AND RISK OF INFECTION (All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when

adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/2011/068) CONTENTS * Device * Problem * Action * Distribution * Feedback * England

* Northern Ireland * Scotland * Wales * Download documents DEVICE Needle-free intravenous connectors. All manufacturers. All models. All brands of needle-free connectors for vascular

access. This includes extension and administration sets with integral connectors. When the valve is activated by an IV device with a male Luer fitting, such as a syringe (without a needle)

or an administration set, the fluid pathway is opened to allow the administration of fluids or aspiration of blood for sampling. Upon removal of the device, the top/septum should

automatically return to its closed/home position and seal the fluid pathway. These connectors are not IV caps, bungs or obturators. PROBLEM * Incompatibility of some pre-filled glass

syringes with various needle-free connectors * Possible risk of infection and/or air embolus to patients when an adaptor remains attached to a needle-free connector after use The MHRA issued

MDA/2004/005 in January 2004 to raise awareness of incompatibility between some needle-free connectors and Luer tips of pre-filled syringes. The MHRA continues to receive reports of damage

to the needle-free connector and/or to the pre-filled syringe where force has been used to connect incompatible devices together. In some cases fragments may block the syringe outflow. Such

damage has resulted in a delay in administering therapy during the resuscitation of patients. The MHRA also continues to receive reports of adverse incidents involving pre-filled glass

syringes used with an adaptor which enables compatibility with a needle-free connector. If the adaptor is not removed from the needle-free connector after administration of fluid via an

intravenous catheter, the IV pathway remains open. This poses a risk of infection and the potential for air embolus. ACTION * Ensure procedures are in place to determine the compatibility of

needle-free connectors in use with pre-filled syringes contained in emergency drug boxes. Refer to the compatibility warnings and Luer size limits in the instructions for use of the

connector. The summary product characteristics (SPC) of the medicine may also include compatibility warnings * Follow the advice on page 2 of this alert if they are not compatible * Ensure

procedures are in place to prevent adaptors being left attached to a needle-free connector after use. If the needle-free connector is not compatible with the pre-filled syringe: * follow any

advice given in the instructions for use * seek an alternative connector or syringe that is compatible, or * use alternative venous access, or * in an emergency, consider removing the

connector or the extension line possessing integral connectors from the intravenous catheter to access the catheter directly * ensure adaptors are removed immediately after use. The MHRA

does not hold a list of incompatible devices. DISTRIBUTION This MDA has been sent to: * NHS trusts in England (Chief Executives) * Care Quality Commission (CQC) (Headquarters) for

information * HSC trusts in Northern Ireland (Chief Executives) * NHS boards in Scotland (Equipment Co-ordinators) * Local authorities in Scotland (Equipment Co-ordinators) * NHS boards and

trusts in Wales (Chief Executives) * Primary care trusts in England (Chief Executives) ONWARD DISTRIBUTION Please bring this notice to the attention of relevant employees in your

establishment. Below is a suggested list of recipients. Trusts CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including: * A&E departments * Adult &

paediatric intensive care units * All medical and nursing staff * All wards and clinical departments * Ambulance staff * Anaesthesia, directors of * Clinical governance leads * Health and

safety managers * Infection prevention nurses * IV nurse specialists * Medical directors * Nursing executive directors * Pharmacists * Purchasing managers * Resuscitation officers and

trainers * Risk managers * Special care baby units * Theatre managers Health Protection Agency Directors for onward distribution to: * Health protection nurses Primary care trusts CAS

liaison officers for onward distribution to all relevant staff including: * Clinical governance leads * Community hospitals * District nurses INDEPENDENT DISTRIBUTION Establishments

registered with the Care Quality Commission (CQC) (England only) This alert should be read by: * Clinics * Hospices * Hospitals in the independent sector * Hospitals in the independent

sector * Independent treatment centres Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs

directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: [email protected] and requesting this facility. FEEDBACK If you have any comments or

feedback on this Medical Device Alert, please email us at: [email protected] ENGLAND If you are in England, please send enquiries about this notice to the MHRA, quoting reference number

MDA/2011/068 or 2011/002/025/081/017 TECHNICAL ASPECTS Sharon Knight or Louise Mulroy Medicines and Healthcare products Regulatory Agency Floor 4 151 Buckingham Palace Road London SW1W 9SZ

Tel: 020 3080 7202 / 7344 Fax: 020 8754 3965 Email: [email protected] [email protected] CLINICAL ASPECTS Jonathan Plumb Medicines and Healthcare products Regulatory

Agency Floor 4 151 Buckingham Palace Road London SW1W 9SZ Tel: 020 3080 7128 Fax: 020 8754 3965 Email: [email protected] HOW TO REPORT ADVERSE INCIDENTS Please report via the

MHRA website Further information about CAS can be found on the CAS website NORTHERN IRELAND 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: [email protected] 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 the NIAIC website  Further information about SABS can be found on the SABS website SCOTLAND 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: [email protected] Incident Reporting and Investigation Centre (IRIC)  WALES 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: [email protected] DOWNLOAD DOCUMENTS Medical

Device Alert: Needle-free intravenous connectors (MDA/2011/068) (402Kb) UPDATES TO THIS PAGE Published 17 December 2014 Contents