Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging (MDA/2018/034)

Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections.

Action

  • Refer to the manufacturer’s Field Safety Notice FSN for a list of affected product codes and affected lots.
  • Stop using and quarantine affected devices as directed in the manufacturer’s FSN.
  • Complete the ‘Recall Response Form for END USERS’ in the FSN and return to convatecproductrecall@stericycle.com to arrange return of affected device(s).
  • Report any incidents or complaints involving this product to unomedical-uk.customerservice@convatec.com.

Action by

All healthcare professionals who are responsible for or who use these devices.

Deadlines for actions

Actions underway: 28 November 2018

Actions complete: 13 February 2018

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

Affected devices can only be identified by comparing product code and manufacture date stated on the packaging to the product list in the manufacturer’s FSN. The breach in the packaging is not visible.

In addition to the FSN, which details the affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information and national supply chain codes (where available).

Manufacturer contacts

ConvaTec Limited Tel: 01244 832206 Email: convatecproductrecall@stericycle.com, unomedical-uk.customerservice@convatec.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 departments
  • All staff
  • All wards
  • 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
  • Clinical perfusionists
  • Colposcopy departments
  • Community children’s nurses
  • Community dental practices
  • Community hospitals
  • Community midwives
  • Community nurses
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • Dental departments
  • District nurses
  • ENT departments
  • ENT medical staff
  • ENT services, directors of
  • Equipment stores
  • Equipment libraries and stores
  • Gastroenterology departments
  • Gastroenterology, directors of
  • Gastro-intestinal surgeons
  • General surgeons
  • General surgery
  • General surgical units, directors of
  • Gynaecologists
  • Gynaecology departments
  • Gynaecology nurses
  • Haemodialysis nurses
  • Haemodialysis units
  • Health and safety managers
  • Hospital at home units
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Intensive care, directors of
  • Minor injury units
  • Maternity units
  • Maxillofacial departments
  • Medical directors
  • Medical libraries
  • Midwifery departments
  • Midwifery staff
  • MRI units, directors of
  • Neonatal nurse specialists
  • Neonatology departments
  • Neonatology directors
  • NHS walk-in centres
  • Nursing executive directors
  • Nutrition nurses
  • Obstetricians
  • Obstetrics and gynaecology departments
  • Obstetrics and gynaecology directors
  • Obstetrics departments
  • Obstetrics nurses
  • Operating department practitioners
  • Oral surgeons
  • Orthopaedic surgeons
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatric intensive care units
  • Paediatric medicine, directors of
  • Paediatric nurse specialists
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Paediatric wards
  • Paediatricians
  • Paediatrics departments
  • Palliative care teams
  • Paramedics
  • Peritoneal dialysis units
  • Purchasing managers
  • Radiographer superintendents
  • Radiographers
  • Radiologists
  • Radiology departments
  • Radiology directors
  • Renal medicine departments
  • Renal medicine, directors of
  • Resuscitation officers and trainers
  • Risk managers
  • School nurses
  • Special care baby units
  • Staff supporting patients receiving haemodialysis at home
  • Sterile services departments
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres
  • Urological surgeons
  • Urological surgery, directors of
  • Urology departments
  • Walk-in centres

NHS England area teams

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

  • General dental practitioners
  • General practitioners
  • Nutritional nurse specialists
  • General practice managers
  • General practice nurses

Social services

Liaison officers for onward distribution to all relevant staff including:

  • Care at home staff
  • Care management team managers
  • Children’s disability services
  • Community care staff
  • Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
  • Disability equipment stores
  • Equipment stores
  • Equipment supplies managers
  • In-house domiciliary care providers (personal care services in the home)
  • In-house residential care homes
  • Loan store managers
  • Loaned equipment store managers

Independent distribution

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

  • Adult placement
  • Care homes providing nursing care (adults)
  • Care homes providing personal care (adults)
  • Clinics
  • Domiciliary care providers
  • Further education colleges registered as care homes
  • Hospices
  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies
  • Private medical practitioners

Independent distribution

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

  • Hospitals in the independent sector
  • Independent treatment centres

Establishments registered with OFSTED

  • Children’s services
  • Educational establishments with beds for children
  • Residential special schools

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/2018/034 or 2018/007/009/291/014

Technical aspects

Emma Rooke and Eliz Mustafa, MHRA

Tel: 020 3080 6609 or 6924

Email: emma.rooke@mhra.gov.uk or eliz.mustafa@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: dct@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card https://yellowcard.mhra.gov.uk/

Northern Ireland

Alerts in Northern Ireland are distributed via the NICAS system.

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

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

https://www.health-ni.gov.uk/niaic

Reporting adverse incidents in Northern Ireland

Please report directly to NIAIC using the forms on our website.

Scotland

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

Incident Reporting and Investigation Centre, Health Facilities Scotland, NHS National Services Scotland

Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division, Welsh Government

Tel: 02920 823 624 / 02920 825 510

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

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card https://yellowcard.mhra.gov.uk/ and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download document

MDA 034

Published 14 November 2018