Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
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| Issued: 22 October 2007 at 11:00 |
Ref: MDA/2007/079
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Immediate action |
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Action |
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Update |
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Information request |
This alert updates and replaces MDA/2007/071 issued 10 September 2007 following receipt of further information from the manufacturer. Additional batch numbers have been added to the list of affected 10ml syringes.
Device:
Syringes: BD Medical Surgical Systems Plastipak™ 1ml, 2ml, 5ml and 10ml hypodermic Luer slip syringes manufactured between April 2007 and August 2007.>Page 2
Problem:
BD Medical Surgical Systems has recently received multiple reports of these syringes spontaneously disconnecting from, or failing to maintain a secure connection to, Luer fittings of other devices.>Page 3
Action by:
All healthcare and care workers who use these devices and those involved in their purchase, supply and distribution.Action:
Ensure local systems are in place to make sure that users:
- use these syringes with caution and avoid their use in situations where disconnection would pose a high risk to patients or users (refer to Problem section)
- follow the manufacturer’s instructions for use provided on the packaging carton to reduce the risk of disconnection (see extract in the Appendix, in pdf only)
- Do not leave these syringes unattended while connected to Luer fittings.
Distributed to:
NHS trusts in England - Chief Executives* OFSTED - Directors of Children's Services Commission for Social Care Inspection (CSCI) - Headquarters Healthcare Commission (CHAI) - Headquarters Primary care trusts in England - Chief Executives* Health Protection Agency (HPA) - Directors * via CE Bulletin
>Page 3
Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.>Page 4
Appendix:
Extract from instructions for use on the carton (in pdf only).>Page 5
MDA/2007/079 - Syringes: BD Medical Surgical Systems Plastipak™ 1ml, 2ml, 5ml and 10ml hypodermic Luer slip syringes manufactured between April 2007 and August 2007 
