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MDA/2006/024 - Baxter Clearlink™ needle-free connector/valve for vascular access

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/024
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN: none
Author:
Copyright: Crown
   

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Page 1

Issued: 12 April 2006 at 11:30
Ref: MDA/2006/024

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Baxter Clearlink™ needle-free connector/valve for vascular access.

>Page 2

Problem:
The instructions for use have undergone significant changes, in particular the maximum period of use of the device.

 

Action by:
All medical and nursing staff responsible for patients with vascular devices. In particular, infection control teams and specialist IV nurses.

 

Action:

  • Ensure that relevant staff are aware of the revised instructions for use contained within the manufacturer's customer letter (see appendix in pdf).
  • Review local policies to ensure consistency with the revised instructions for use, incorporate changes and modify training.
  • The manufacturer is in the process of incorporating the revised instructions for use into the instructions supplied with the device. Following this action, previous editions of the instructions for use should be disregarded and destroyed.

>Page 2

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

>Page 2

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 3

Appendix:
Baxter customer letter.

See download document


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 10 May 2006
Deadline (action complete): 07 June 2006


Page last modified: 07 February 2008