Medical Device Alert: X-ray detectable gauze swabs manufactured by Frontier Multigate (MDA/2012/078)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/078 or 2012/010/010/401/004

Technical aspects
Mojisola Ajeneye / Sally Mounter
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel:    020 3080 7271/7168
Fax:   020 8754 3965
Email:  mojisola.ajeneye@mhra.gsi.gov.uk or sally.mounter@mhra.gsi.gov.uk

Clinical aspects
Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel:    020 3080 7126
Fax:   020 8754 3965
Email:  nicola.lennard@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

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website (external link)
Further information about SABS can be found on the SABS website (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

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (external link)

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

The X-ray detectable thread may shred during use due to excessive irradiation during manufacturing.

If a swab without the X-ray thread present is left inside the patient, it will not be detectable by X-ray examination. Any material shed from the gauze swabs, although not toxicologically harmful, may cause inflammation and potentially also granulation of tissue.

• Identify, do not use and quarantine swabs from the affected lot.
• Ensure that all relevant staff are aware of this recall.
• Follow the advice in the manufacturer’s Field safety Notice (160Kb) (issued in October 2012).

Action by

All those involved in the use and supply of these devices.

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)
• Health and Safety Executive
• Primary care trusts in England (chief executives)

Onward distribution

• A&E departments
• All wards
• All theatres
• Day surgery units
• Directors of nursing
• General surgical units, directors of
• Medical directors
• Radiographers
• Radiologist
• Risk managers
• Supplies managers
• Surgeons
• Theatre managers

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

This alert should be read by:

• Hospitals in the independent sector
• Independent treatment centres
• 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 Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Mr Derek Lloyd
Frontier Multigate
Newbridge Road Industrial Estate
Blackwood
South Wales
NP12 2 YN

Tel: 01495 233 050    

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