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MDA/2008/016 - Needle-free intravascular connectors. All brands

Document details:

Type: Medical Device Alert
Series No: MDA/2008/016
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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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.

Page 1

Issued: 18 March 2008 at 12:00
Ref: MDA/2008/016

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Needle-free intravascular connectors. All brands.

>Page 2

Problem:
There is a risk of infection if the top/septum of the connector remains recessed within its housing. Swabbing of the connector in this condition may lead to inadequate decontamination.

>Page 2

Action by:
All medical and nursing staff, particularly infection control nurses and IV specialist nurses.
 

Action:

  • Prior to accessing the device and following use of the device, ensure that the top/septum of the connector is in its closed/home position. This position may vary between brands.
  • Follow the manufacturer's instructions for use with regard to any warnings and recommendations relating to a recessed connector.
  • For application of clamps to IV line/catheters fitted with these connectors, follow the manufacturer's instructions for use.
  • After following the above, if the top/septum remains recessed, replace the connector and report the incident to the MHRA.
 

Distributed to:

NHS trusts in England - Chief Executives*
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

>Pages 2-3

Contacts:
Details of MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

>Page 3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 18 April 2008
Deadline (action complete): 19 May 2008


Page last modified: 18 March 2008