Medical Device Alert: Suction catheters. OP-Flex Poole manufactured by Unomedical LTD (MDA/2009/034)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/034 or 2009/003/023/061/011.

Technical aspects
Roopa Prabhakar or Louise Mulroy
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3293/3344
Fax: 020 7084 3209
E-mail: roopa.prabhakar@mhra.gsi.gov.uk or louise.mulroy@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111
E-mail: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900
E-mail: NIAIC@dhsspsni.gov.uk
http://www.dhsspsni.gov.uk/index/hea/niaic.htm

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on our website: http://www.dhsspsni.gov.uk/niaic 

Further information about SABS can be found at https://sabs.dhsspsni.gov.uk

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
E-mail: iric@shs.csa.scot.nhs.uk
http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922
E-mail: Haz-Aic@wales.gsi.gov.uk

Risk of the suction catheter’s outer Poole cover detaching from the handle and remaining in the patient due to a manufacturing fault.

If you purchase procedure packs from CalMed, Molnlycke, Rocialle or Unisurge, check the manufacturer’s Field Safety Notices to see if your stock is affected. If your packs are affected or you are unsure, contact the relevant manufacturer of the procedure pack.

Field Safety Notices are available on the MHRA website.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)
• Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• A&E departments
• All wards
• Ambulance staff
• Anaesthesia, directors of
• Anaesthetists
• Anti-coagulation clinics
• EBME departments
• Equipment stores
• Intensive care units
• Maintenance staff
• Nursing executive directors
• Radiology departments
• Resuscitation officers
• Risk managers
• Supplies managers
• Theatre managers
• Theatre nurses
• Theatres

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Care homes providing nursing care (adults)
• Hospices
• Hospitals in the independent sector

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

• Community hospitals
• General dental practitioners

Change of address or removal from address list for Care Quality Commission:
National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61
E-mail: enquiries@cqc.org.uk

Manufacturer

Debbie Mertens
Quality Assurance
First Floor, Unit 3 West Wing
Brooklands, Moons Moat Drive
Redditch, Worcester
B98 9DW

Tel: 01527 583 600 Ext 226
Fax: 01527 591 198
E-mail: debbie.mertens@unomedical.com

Affected product reference numbers and lot numbers of Unomedical OP-Flex Poole suction catheters.