- Identify the affected devices as stated in the manufacturer’s Field Safety Notice (FSN).
- Ensure that all users receive the manufacturer’s FSN and that they understand the problem and actions to be taken.
- Refer to the FSN for actions to be taken.
- Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
All healthcare staff involved with patient ventilation.
Deadlines for actions
Actions underway: 3 October 2018
Actions complete: 17 October 2018
Medical Device Safety Officers (in England)
Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
The manufacturer found certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
If disconnection occurs during use, it will result in an open respiratory circuit and interrupt patient ventilation.
Telephone +32 (2) 7112668
Email: Veronique.Paulin@hyh.com or _EMEAFieldAction@hyh.com.
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- Adult intensive care units
- All wards
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Community children’s nurses
- Community hospitals
- Community nurses
- ENT departments
- ENT medical staff
- ENT services, directors of
- Hospital at home units
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Operating department practitioners
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric oncologists
- Paediatric surgeons
- Paediatric surgery, directors of
- Paediatric wards
- Patient transport managers
- Theatre managers
- Theatre nurses
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
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@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/030 or 2018/003/009/478/014.
Zarah Naeem or Richard Adu-Ntow, MHRA
020 3080 6930/7072
Email: firstname.lastname@example.org or email@example.com
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NICAS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).