Medical Device Alert: Receptal 1, 1.5 and 2 litre PVC suction liners manufactured by Hospira (formerly manufactured by Abbott) (MDA/2010/065)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/064 or 2010/007/023/081/016.

Technical aspects
Graham Nash or Nicole Small
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3125 / 3310
Fax: 020 7084 3209

Email: graham.nash@mhra.gsi.gov.uk or nicole.small@mhra.gsi.gov.uk

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

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@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 Central Alerting System website (external link).

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

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

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 (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

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

Due to a manufacturing fault, the lid of Receptal PVC suction liners may not be correctly aligned.

When fitted to the suction canister this can result in an inadequate seal and loss of suction.

To date, up to 10% of the affected suction liners have exhibited misaligned lids.

• Ensure that users are aware of the risk of failure.
• Perform the pre-use checks described in Hospira’s Field Safety Notice.
• Ensure that spare suction liners are available at the point of use.

All liners should be checked according to the Hospira Field Safety Notice, including those which have already been placed into a suction canister ready for use.

In addition to the recommendations in Hospira’s Field Safety Notice, the MHRA recommends referring to the instructions for use provided by the manufacturer of the suction unit or suction canister for their assembly instructions and recommended pre-use checks.

Hospira implemented a corrective action in June 2010, but as the manufacturing date cannot easily be identified, pre-use checks should always be carried out.

The MHRA has issued this Medical Device Alert to ensure that users are aware of this problem and to remind them of previously published guidance – MDA/2005/035.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)

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
• Adult intensive care units
• All wards and clinical departments
• Ambulance staff
• Clinical governance leads
• Day surgery units
• Dentists
• EBME departments
• General surgery
• Intensive care units
• Medical directors
• Outpatient clinics
• Outpatient theatre managers
• Physiotherapists
• Resuscitation officers and trainers
• Surgeons
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

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

OFSTED to:
The MHRA considers this to be important to:

• Educational establishments with beds for children
• Residential special schools

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

• Community dental practices
• Community hospitals
• Minor injury units
• NHS walk-in centres

Social services to:
Liaison officers for onward distribution to all relevant staff including:

• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
• In-house residential care homes

Geraint Morgan
Manager, Medical Information
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW

Tel: 01926 834 400

Email: medinfouk@hospira.com