LMA mucosal atomization devices - topical anaesthesia may not be delivered in a fully atomised spray

Manufactured by Teleflex – Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia

Action

  • Identify and quarantine affected devices (see below).
  • Contact Teleflex to acknowledge receipt of their field safety notice FSN
  • Return all affected devices to Teleflex.

Action by

All healthcare workers who use these devices.

Deadlines for actions

Actions underway: 2 weeks

Actions complete: 2 months

Device details

See attached PDF for the affected devices.

These products are used for the delivery of topical anaesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa.

Note there is a separate MDA for Teleflex LMA MAD devices used to deliver medication suitable for nasal delivery, MDA/2017/XX

Manufacturer contacts

Teleflex Customer Service
Tel: : 01494 532761

Email orders.uk@teleflex.com

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 SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E departments
  • Adult intensive care units
  • Ambulance staff
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospices
  • Hospitals in the independent sector
  • Independent treatment centres
  • Private medical practitioners

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/yyyy/nnn or 2016/010/031/299/012

Technical aspects

Emma Rooke or Suleman Hussain, MHRA

Tel: 020 3080 6609 / 6956

Email: emma.rooke@mhra.gov.uk or suleman.hussain@mhra.gov.uk

Clinical aspects

MHRA Devices Clinical Team

Tel: 020 3080 7274

Email: DCT@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

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,
CMO Group,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Web: www.health-ni.gov.uk/niaic

Reporting adverse incidents in Northern Ireland

Please report directly to NIAIC using the forms on our 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
Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

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.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510

Email:Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales)

Download document

LMA mucosal atomization devices - topical anaesthesia may not be delivered in a fully atomised spray

Published 24 April 2017