Medical Device Alert: Endotracheal (ET) tubes, adult and paediatric sizes manufactured by Unomedical (MDA/2010/027)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/027 or 2010/001/012/081/007

Technical aspects
Douglas McIvor or Louise Mulroy
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3193 / 3344
Fax: 020 7084 3209

Email: douglas.mcivor@mhra.gsi.gov.uk or louise.mulroy@mhra.gsi.gov.uk

Clinical aspects 
Tom Clutton-Brock
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3056
Fax: 020 7084 3111

Email: tom.clutton-brock@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel: 028 9052 3704
Fax: 028 9052 3900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

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

Risk of inadvertent disconnection of the endotracheal tube from the breathing system, interrupting patient ventilation until the tube is reconnected or replaced.

A manufacturing irregularity during production of these ET tubes from August 2008 to November 2009 has been identified. This has caused the potential for the connector to detach from the ET tube more easily than expected. To address this potential problem the manufacturer is recalling affected lots.

A Field Safety Notice (FSN) was issued by the manufacturer in January 2010. The manufacturer was having difficulties in identifying which of the affected lots had been distributed in the UK and therefore issued an updated FSN in March 2010. That FSN was supported by the MHRA with MDA/2010/024.

The manufacturer has now discovered that additional affected lots have been distributed in the UK and so has published a third FSN in April 2010. This Update MDA has been issued to support the April FSN and contains the lot numbers of all affect devices.

• Check lot numbers to identify whether you have affected devices.
• Do not use affected devices.
• Return affected products to the supplier for credit.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

• A&E departments
• all wards
• ambulance staff
• anaesthetic nursing staff
• anaesthetists
• day surgery units
• high dependency units
• intensive care units
• maternity units
• midwifery departments
• operating department practitioners
• paediatric outpatients
• paediatric wards
• paediatric intensive care units
• paramedics
• resuscitation officers and trainers
• risk managers
• special care baby units
• theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• hospitals in the independent sector
• independent treatment centres

Sara Collins
Unomedical

Tel: 01527 583 622
Fax: 01527 591198

Email: Sara.Collins@convatec.com