The manufacturer initially issued a Field Safety Notice (FSN) highlighting this issue in May 2019, but an updated version was circulated in August 2019 expanding the range of affected devices.
- Identify and quarantine affected devices in stock (see Appendix 2 of the FSN dated 6 August 2019).
- For devices currently in use, follow the guidance in the FSN.
- Complete the ‘Field Safety Corrective Action Acknowledgement Form’ in Appendix 1 of the FSN even if you don’t have affected devices left in stock, and return it to firstname.lastname@example.org to arrange return of affected devices.
- Even if you completed the acknowledgement form in the earlier version of the FSN, you need to also complete the one in the updated FSN.
- Report suspected or actual 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 professionals involved in the use of these devices
Deadlines for actions
- Actions underway: 24 October 2019
- Actions complete: 14 November 2019
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.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
In addition to the manufacturer’s Field Safety Notice, which details affected product, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.
Tel: 0149 453 2761
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
- A&E directors
- A&E nurses
- Adult intensive care units
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Day surgery units
- Dental departments
- Dental nurses
- ENT departments
- ENT medical staff
- ENT services, directors of
- Equipment stores
- Equipment libraries and stores
- General surgeons
- General surgery
- General surgical units, directors of
- Gynaecology departments
- Gynaecology nurses
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Operating department practitioners
- Ophthalmic nurses
- Ophthalmology departments
- Ophthalmology, directors of
- Oral surgeons
- Orthopaedic surgeons
- Outpatient theatre managers
- Outpatient theatre nurses
- Supplies managers
- Theatre managers
- Theatre nurses
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
- 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 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/2019/036 or 2019/005/030/487/001.
Emma Rooke and Ben Satchell, MHRA
Tel: 020 3080 6000
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)
Tel: 0208 9052 3868
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can't access the webform, visit the website: how to report an adverse incident
Population Healthcare Division, Welsh Government
Tel: 03000 255278 / 03000 255510
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).