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Medical Device Alert: Crystal® Metal disposable laryngoscope blades (size Mac 4) manufactured by Penlon Ltd (MDA/2011/101)

Document details:

Type: Medical Device Alert
Series No: MDA/2011/101
Audience: Healthcare professionals
Published: 2 November 2011 at 11:30
Format: Electronic only
Size: A4
Pages: 4
Price: Free
ISBN/ISSN: None
Author:
Copyright: Crown
   

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CAS deadlines
Action underway: 9 November 2011, action complete 16 November 2011

Ref: MDA/2011/101 | Issued: 2 November 2011 at 11:30

  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/2011/101 or 2011/010/021/081/001.

Technical aspects
Dr Louise Mulroy and Ms Emma Rooke
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7344 or 6609
Fax: 020 8754 3965

Email: louise.mulroy@mhra.gsi.gov.uk or emma.rooke@mhra.gsi.gov.uk

Clinical aspects
Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 6800
Fax: 020 8754 3965

Email: emma.rooke@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 CAS 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: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (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

Heath Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (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

Crystal® Metal disposable laryngoscope blades (size Mac 4).Crystal® Metal disposable laryngoscope blades (size Mac 4).

With expiry dates up to and including August 2016.

Manufactured by Penlon Ltd.

Mac 3 blades have been incorrectly packaged and labelled as Mac 4 blades.

Penlon issued an updated Field Safety Notice (FSN) on 14 October 2011, which contains corrected expiry dates for the affected blades.

All devices labelled as size Mac 4 with expiry dates up to and including August 2016 are potentially affected.

Penlon has not had sufficient confirmation from users that they have received and acted on the updated FSN.

Penlon initially issued a FSN on 14 September 2011 but it did not include the details of all potentially affected products.

  • Ensure that relevant members of staff are aware of the updated information in the FSN.
  • Identify MAC 4 blades with expiry dates up to and including August 2016.
  • Quarantine affected devices if the sizes etched on the blades do not match the size indicated on the packaging (pouch and carton).
  • Return Penlon’s reply form to confirm receipt of the FSN and provide details of any mislabelled blades.

Action by
All theatre staff, anaesthetists, intensive care staff, ENT staff, A&E departments and stores personnel.

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (headquarters) for information
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • 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 relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) 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
  • All adult wards
  • Ambulance services directors
  • Ambulance staff
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Day surgery units
  • ENT units
  • Equipment stores
  • General surgery
  • General surgical units, directors of
  • Intensive care medical staff
  • Intensive care units
  • Intensive care, directors of
  • Medical directors
  • Nursing executive directors
  • Outpatient theatre managers
  • Paramedics
  • Purchasing managers
  • Resuscitation officers
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

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

  • Equipment libraries and stores
  • Practice managers
  • Resuscitation officers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Hospitals in the independent sector

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 Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Lynda McConaghy or Dr Angela Dunford
Penlon Ltd
Abingdon Science Park
Barton Lane
Abingdon
OX14 3PH

Tel: 01235 547 025 or 01235 547 093

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk  
Page last modified: 02 November 2011