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MDA/2008/064 - Obturator - Venflon IV cannula obturator manufactured by BD

Document details:

Type: Medical Device Alert
Series No: MDA/2008/064
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 04 September 2008 at 11:00
Ref: MDA/2008/064

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Obturator – Venflon™ IV cannula obturator manufactured by BD. Product code numbers 394252 and 394253. Various lot numbers.

>Page 2

Problem:
Due to a manufacturing problem, there may be cracks and holes in the packaging of the listed obturators for Venflon™ cannulae, which could compromise sterility.
 
Action by:
All staff who use, supply or purchase this device.
 

Action:

  • Identify and isolate the affected devices.
  • Do not use the affected devices.
  • Contact the manufacturer to arrange for return and replacement of the devices.
 

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*
NHS Boards in Scotland  - Chief Executives

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer 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 September 2008
Deadline (action complete): 06 October 2008


Page last modified: 04 September 2008