BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking (MDA/2019/044)
Manufactured by Flexicare Medical – loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.
Action
All healthcare professionals who are responsible for or who use these devices.
- Check all stock for affected devices listed in the manufacturer’s Field Safety Notice (FSN).
- Quarantine all affected stock immediately.
- Complete the response form on the FSN and return to the manufacturer.
- If you do not have any of the affected devices, please indicate this on the response form.
- Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Note: the last MDA we issued (MDA/2019/043) was not sent to all organisations - more information here.
Action by
All healthcare professionals who use these devices.
Deadlines for actions
Actions underway: 19 December 2019
Actions complete: 06 January 2020
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
Device details
| Part number | Product description | Lot numbers | NHS Supply Chain code |
|---|---|---|---|
| 040-333 | BritePro Solo Single Use Fibre Optic Laryngoscope Handle and Macintosh Blade Size 3 | 180802595 180900401 180901083 181100289 181100290 181100301 181200353 181201031 | FSM1632 |
| 040-342 | BritePro Solo Single Use Fibre Optic Laryngoscope Handle and Miller Blade Size 2 | 190100335 | FSM3313 |
| 040-713 | BriteBlade Pro Single Use Fibre Optic Macintosh Blade Size 3 | 180900316 181102912 180900404 | FSM1363 |
Manufacturer contacts
Flexicare Medical
Email: Quality@Flexicare.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 NICAS 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 wards
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Equipment stores
- Equipment libraries and stores
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Operating department practitioners
- Resuscitation officers and trainers
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
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 Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/044 or 2019/010/010/701/010.
Technical aspects
Ben Satchell or Emma Rooke, MHRA
Tel: 020 3080 6000
Email: DSS-TM@mhra.gov.uk
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: dct@mhra.gov.uk
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)
Tel: 028 9052 3868
Email: niaic@health-ni.gov.uk
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can't access the webform, visit the website: how to report an adverse incident
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 255278 or 03000 255510
Email: Haz-Aic@gov.wales
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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