Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit (MDA/2019/033)
Manufactured by Intersurgical – leaks or disconnection can result in insufficient oxygenation requiring medical intervention to avoid severe injury.
Action
- Check all stock for affected devices listed in the manufacturer’s Field Safety Notice (FSN).
- Before use, check the connection between the taper and the mating device as described in the FSN and instructions for use.
- If you identify any problems with these devices, contact the manufacturer to arrange return and replacement of the devices.
- Complete the response form supplied in the FSN and return to Intersurgical, even if you no longer have affected devices in stock.
- 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.
Action by
All healthcare professionals who are responsible for, or who use these devices.
Deadlines for actions
Actions underway: 15 October 2019
Actions complete: 29 October 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.
Manufacturer contacts
Intersurgical
Tel: 0118 9656362
Email: priority@intersurgical.co.uk
Distribution
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
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Clinical perfusionists
- Day surgery units
- EBME departments
- Equipment stores
- 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
- Oral surgeons
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric wards
- Paramedics
- Resuscitation officers and trainers
- Risk managers
- Special care baby units
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
Independent distribution
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: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/033 or 019/007/010/228/003.
Technical aspects
Ben Satchell or Enitan Taiwo, MHRA
Tel: 020 3080 6000
Email: DSS-TM@mhra.gov.uk
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: dct@mhra.gov.uk
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)
Tel: 0208 9052 3868
Email: niaic@health-ni.gov.uk
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.
Scotland
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
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
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 255278 / 03000 255510
Email: Haz-Aic@gov.wales
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).
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