- Ensure all users are aware of the potential for the set’s needle to break (see field safety notice (FSN) for details of affected sets).
- Ensure procedures are in place for all users, including patients, to:
- check the infusion sets prior to use and do not use sets with bent or damaged needles
- remove sets carefully and check that they are intact after use
- receive and understand the instructions for use
- contact a health care provider for clinical assessment if a needle has broken
All healthcare workers who use these devices and personnel involved in the purchase, supply and distribution of these devices, particularly:
- Parkinson’s nurse specialists
- diabetes nurse specialists
- haematology nurse specialists
Deadlines for actions
Actions underway: 6 August 2015, actions complete: 23 October 2015
The following steel cannula infusion sets are affected:
- SURE-T Paradigm
- contact detach
- Sub Q
- neria detach
- neria multi
Further device details including lot numbers and item numbers are in the manufacturer’s FSN.
Unomedical a/s issued an FSN in May 2015 to distributors but does not know where all the sets were sent.
Telephone: +45 4642 7880
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- All wards
- Clinical governance leads
- Community diabetes specialist nurses
- Community hospitals
- Community nurses
- Day surgery units
- Diabetes clinics/outpatients
- Diabetes nurse specialists
- District nurses
- Endocrinology units
- Health visitors
- Hospital at home units
- Medical directors
- Nursing executive directors
- Palliative care teams
- Parkinson’s nurse specialists
- Purchasing managers
- Risk managers
- Supplies managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- Community pharmacists
- General practitioners
- General practice nurses
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team managers
- Community care staff
- In-house residential care homes
Establishments registered with the Care Quality Commission (CQC) (England only)
- Care homes providing nursing care (adults)
- Hospitals in the independent sector
- Nursing agencies
- Private medical practitioners
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/2015/027 or 2014/007/002/081/042.
Sharon Knight or Patrick Sweeney, MHRA
Telephone: 020 3080 7202 / 6898
Email: firstname.lastname@example.org or email@example.com
Mark Grumbridge, MHRA
Telephone: 020 3080 7128
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Department of Health
Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Northern Ireland Adverse Incident Centre (NIAIC)
Reporting adverse incidents in Northern Ireland
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
Telephone: 0131 275 7575
Fax: 0131 314 0722
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
Telephone: 01267 225278 / 02920 825510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).