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Ref: MDA/2010/017
Device
Peripheral cannula.
Nexiva closed IV catheter
system with Q-Syte connector.
Manufactured by Becton
Dickinson.
Problem
Action
The manufacturer has received reports of air
entering into infusion lines through the
BD Q-Syte connector.
Risk of air embolus to patients.
This problem is an extension of the original
action detailed in MDA/2009/075.
• Quarantine and do not use devices
from affected lot numbers.
• Contact Becton Dickinson to arrange
for credit or replacement product.
Action by
All medical and nursing staff.
CAS deadlines
Contact
Action underway: 15 March 2010
Action complete: 22 March 2010
Manufacturer
Customer Services
Becton Dickinson
Tel: 01865 781 517
Fax: 01865 781 501
E-mail: val_mummery@europe.bd.com
Device
This IV system has one Q-Syte connector attached to the cannula and another Q-Syte connector contained
within the unit packaging for use after insertion.
Affected batches were supplied to UK customers from January to August 2009 inclusive. The details of the
affected devices are shown below.
Product code
NHS Supply Chain code
Lot numbers
383531
FSP2235
8305438, 8308349,
8345951, 9026722
383532
FSP2236
8248349, 8259950,
8296792, 8322609,
8338738
383536
FSP2237
8248355, 8249034,
8249035, 8269338,
8270576, 8274565,
8275207, 8275210,
8312211, 8347056,
9007360
383539
FSP2238
8263293, 8274555,
8275429, 8290311,
8340308
383530
8238450, 8319936
8345957
383540
8340302
Problem
Becton Dickinson issued a Field Safety Notice to customers on 2 November 2009 to withdraw certain lot
numbers of the Q-Syte needle-free connector due to the risk of air embolism and this was supported by
MDA/2009/075.
The manufacturer has extended the original action to include certain lot numbers of the Nexiva peripheral
cannula, which include Q-Syte connectors that may be affected by this problem, and issued a Field Safety
Notice to customers on 12 February 2010. The MHRA has issued this Medical Device Alert to ensure that
users are aware of this problem.
Distribution
This MDA has been distributed to:
• NHS trusts in England (Chief Executives)
• Health Protection Agency (HPA) (Directors)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)
Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. |
