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Medical Device Alert: Endotracheal tube manufactured by Smiths Medical (MDA/2009/063)

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Document details:

Type: Medical Device Alert
Series No: MDA/2009/063
Audience: Healthcare professionals
Published: 14 October 2009 at 14:30
Format: Electronic only
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Immediate action

Ref: MDA/2009/063 | Issued: 14 October 2009 at 14:30

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer contacts
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/063 or 2009/008/013/081/007.

Technical aspects
Nicola Ridd or Geoff Ali
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3039 / 3102
Fax: 020 7084 3209

Email: nicola.ridd@mhra.gsi.gov.uk or geoff.ali@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

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 Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

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

Endotracheal tube. Portex uncuffed paediatric tracheal tubes, manufactured by Smiths Medical.

Portex uncuffed paediatric tracheal tubes, manufactured by Smiths Medical

Tube sizes 2.0, 2.5, 3.0 and 3.5 mm. This is a single-use device, intended to aid management of compromised airways in paediatric patients.

All product codes listed below, with a manufacturing date prior to September 2009, are being recalled.

Note: it is not known how many of the tubes being recalled are actually undersized.

Product code Product description
100/105/025 Portex ® Tracheal Tube, Oral/Nasal, Ivory
100/105/030 Portex ® Tracheal Tube, Oral/Nasal, Ivory
100/105/035 Portex ® Tracheal Tube, Oral/Nasal, Ivory
100/111/020 Portex ® Tracheal Tube, Oral/Nasal, Siliconised
100/111/025 Portex ® Tracheal Tube, Oral/Nasal, Siliconised
100/111/030 Portex ® Tracheal Tube, Oral/Nasal, Siliconised
100/111/035 Portex ® Tracheal Tube, Oral/Nasal, Siliconised
100/112/025 Portex ® Paediatric Croup Tracheal Tube, Extra Length, Oral/Nasal, Murphy Eye, Siliconised
100/112/030 Portex ® Paediatric Croup Tracheal Tube, Extra Length, Oral/Nasal, Murphy Eye, Siliconised
100/112/035 Portex ® Paediatric Croup Tracheal Tube, Extra Length, Oral/Nasal, Murphy Eye, Siliconised
100/126/025 Portex ® Tracheal Tube, Cut to Length, Oral, Siliconised
100/126/030 Portex ® Tracheal Tube, Cut to Length, Oral, Siliconised
100/126/035 Portex ® Tracheal Tube, Cut to Length, Oral, Siliconised
100/127/025 Portex ® Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/127/030 Portex ® Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/127/035 Portex ® Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/132/030 Portex ® Polar Preformed Tracheal Tube, North Oral, Murphy Eye, Clear
100/132/035 Portex ® Polar Preformed Tracheal Tube, North Oral, Murphy Eye, Clear
100/134/030 Portex ® Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear
100/134/035 Portex ® Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear
100/141/025 Portex ® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconised
100/141/030 Portex ® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconised
100/141/035 Portex ® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconised
100/605/025 Portex ® Paediatric Tracheal Tube with Holder, Oral/Nasal, Ivory
100/605/030 Portex ® Paediatric Tracheal Tube with Holder, Oral/Nasal, Ivory
100/605/035 Portex ® Paediatric Tracheal Tube with Holder, Oral/Nasal, Ivory
100/611/020 Portex ® Paediatric Tracheal Tube with Holder, Oral/Nasal, Siliconised
100/611/025 Portex ® Paediatric Tracheal Tube with Holder, Oral/Nasal, Siliconised
100/611/030 Portex ® Paediatric Tracheal Tube with Holder, Oral/Nasal, Siliconised
100/611/035 Portex ® Paediatric Tracheal Tube with Holder, Oral/Nasal, Siliconised


A manufacturing defect has resulted in some tubes having an internal diameter slightly smaller than indicated on the labelling.

The small diameter may cause a problem when suctioning a patient, and may also increase airway resistance, compromising the ability to ventilate the patient.

  • Check stock to identify affected batches.
  • Contact Smiths Medical to arrange for their return and replacement or credit.
  • While waiting for replacement product, or if no replacement/alternatives are available, clinicians should follow the recommendations for suction catheter sizes on the Smiths Medical size guidance chart given in their Field Safety Notice (21 September 2009).

This MDA has been distributed to:

  • NHS trusts in England (Chief Executives)
  • Care Quality Commission (CQC) (Headquarters)
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Chief Executives)
  • NHS boards and trusts in Wales (Chief Executives)
  • Primary care trusts in England (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:

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

  • hospitals in the independent sector
  • independent sector treatment centres.

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

  • A&E departments
  • adult intensive care departments
  • anaesthetists
  • ENT departments
  • ENT surgeons
  • Intensive care specialists
  • neonatology departments
  • paediatric intensive care units
  • paediatric wards
  • paediatricians
  • paediatrics departments
  • paramedics
  • purchasing managers
  • resuscitation officers
  • risk managers
  • special care baby units
  • supplies managers
  • theatre managers.

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

  • resuscitation officers.

UK Customer Services
Smiths Medical International Limited
Colonial Way
Watford
WD24 4LG

Tel: 01923 475 990
Fax: 01923 255 790

Email: ukcs@smiths-medical.com

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk
Page last modified: 14 October 2009