Various trauma guide wires – risk of infection due to packaging failure (MDA/2018/032)

Manufactured by Zimmer Biomet with expiry dates prior to 31 May 2028 – wire may breach packaging, compromising sterility of device.

Action

  • Locate, quarantine and return all affected product.
  • Return acknowledgement document to manufacturer (or complete online form as stated in the Field Safety Notice (FSN)).

Action by

All healthcare professional involved in the purchase and use devices

Deadlines for actions

Actions underway: 22 October 2018

Actions complete: 12 November 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 with expiry date prior to 31 May 2028:

Item Number Item Description
469360 green
469340 yellow
469320 green
469060 yellow
469055 green
469040 yellow
469020 green
467265 yellow
467260 green
467220 yellow
29402 green
14-443053 yellow
14-443023 green
14-441053 yellow

Manufacturer contacts

Zimmer Biomet
Red Dragon Court, Unit 2, South Road
Bridgend Industrial Estate
Bridgend
South Wales
CF13 3PT

Tel: 01656 333932 Email: fieldaction.uk@zimmerbiomet.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:

  • Infection control departments
  • Infection control nurses
  • Infection prevention and control directors
  • Microbiologists
  • Orthopaedic surgeons
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

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
  • PHE laboratories
  • Regional microbiologists
  • Risk manager
  • Safety officers

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/2018/032 or 2018/006/021/701/023

Technical aspects

Sara Vincent or Catriona Blake, MHRA

Tel: 020 3080 7169 or 7219

Email: sara.vincent@mhra.gov.uk or catriona.blake@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

Various trauma guide wires – risk of infection due to packaging failure (MDA/2018/032)

Published 24 September 2018