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

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Issued: 22 October 2007 at 11:00

Ref: MDA/2007/079

 

	Immediate action
	Action
	Update
	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

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 29 October 2007	Deadline (action complete): 22 November 2007