Product information

MDA number

MDA/2020/004

Company name

Mavidon Medical

Summary

Manufactured by Mavidon – products may be contaminated with the microorganism Burkholderia cepacia leading to an infection risk to patients.

Action

identify and quarantine all lots of the affected products in your organisation, using the manufacturer’s field safety notice

if you have the affected products, fill in the recall form in the FSN and return it to the manufacturer

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

Action by

All responsible for the use of these devices.

Deadlines for actions

Actions underway: 19 February 2020 Actions complete: 4 March 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.

Problem / background

The manufacturer identified an issue at their manufacturing facility which means products are potentially contaminated with Burkholderia cepacia, a drug-resistant microorganism. They are now recalling all products made at this site that use the affected production method.

Mavidon Medical Tel: +1 561 585 2227 Email: cs@mavidon.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

Ambulance services directors

Ambulance staff

Anaesthesia, directors of

Anaesthetic medical staff

Anaesthetic nursing staff

Anaesthetists

Cardiac laboratory technicians

Cardiac pacing technicians

Cardiologists

Cardiology departments

Cardiology nurses

Cardiology, directors of

Cardiothoracic departments

Cardiothoracic surgeons

Cardiothoracic surgery directors

Clinical governance leads

Colposcopy departments

Community hospitals

Coronary care departments

Coronary care nurses

Day surgery units

Dental departments

Dental nurses

Dentists

Endocrinology units

Endocrinology, directors of

ENT departments

ENT medical staff

ENT services, directors of

Equipment stores

Equipment libraries and stores

Gastroenterology departments

Gastroenterology, directors of

General surgery

General surgical units, directors of

Gynaecologists

Gynaecology departments

Gynaecology nurses

Haematologists

Haemodialysis nurses

Haemodialysis units

Health and safety managers

Infection control departments

Infection control nurses

Infection prevention and control directors

Intensive care medical staff/paediatrics

Intensive care nursing staff (adult)

Intensive care nursing staff (paediatric)

Intensive care units

Intensive care, directors of

IV nurse specialists

Minor injury units

Maternity units

Medical directors

Microbiologists

Midwifery departments

Midwifery staff

MRI units, directors of

Neonatal nurse specialists

Neonatology departments

Neonatology directors

NHS walk-in centres

Nursing executive directors

Obstetricians

Obstetrics and gynaecology departments

Obstetrics and gynaecology directors

Obstetrics departments

Obstetrics nurses

Operating department practitioners

Ophthalmology departments

Ophthalmology, directors of

Oral surgeons

Outpatient clinics

Outpatient theatre managers

Outpatient theatre nurses

Paediatric intensive care units

Paediatric medicine, directors of

Paediatric nurse specialists

Paediatric surgery, directors of

Paediatric wards

Paediatrics departments

Paramedics

Peritoneal dialysis units

Purchasing managers

Radiology departments

Renal medicine departments

Renal medicine, directors of

Resuscitation officers and trainers

Risk managers

Special care baby units

Supplies managers

Theatre managers

Theatre nurses

Theatres

Urological surgeons

Urological surgery, directors of

Urology departments

Walk-in centres

Public Health England

Directors for onward distribution to:

Collaborating centres

Consultants in communicable disease control

Divisional directors

Heads of department

Heads of health, safety and quality

Health protection nurses

Laboratory managers

PHE laboratories

Regional microbiologists

Risk manager

Safety officers

GP Practices registered with CAS

This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.

NHS England area teams

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

General dental practitioners

GP practices not yet registered with CAS (for information only)

Occupational health departments

This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

Clinics

Hospices

Hospitals in the independent sector

Independent treatment centres

Nursing agencies

Private medical practitioners

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/2020/004 or 2020/001/007/228/002.

Technical aspects

Phillip Davenport, 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

Download document

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