- Medicines and Healthcare products Regulatory Agency
- 24 April 2017
- 24 April 2017
- Alert type:
- Medical device alert
Manufactured by Teleflex – Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia
- Identify and quarantine affected devices (see below).
- Contact Teleflex to acknowledge receipt of their field safety notice FSN
- Return all affected devices to Teleflex.
All healthcare workers who use these devices.
Deadlines for actions
Actions underway: 2 weeks
Actions complete: 2 months
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
Teleflex Customer Service
Tel: : 01494 532761
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
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
Send enquiries about this notice to MHRA, quoting reference number MDA/yyyy/nnn or 2016/010/031/299/012
Emma Rooke or Suleman Hussain, MHRA
Tel: 020 3080 6609 / 6956
MHRA Devices Clinical Team
Tel: 020 3080 7274
Reporting adverse incidents in England
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
Tel: 028 9052 3868
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
Tel: 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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 24 April 2017
Issued: 24 April 2017
Alert type: Medical device alert