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BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300
Notice type:
Advisory
Date:
28/02/2014
Product name or type:
BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300
Reference:
SN2014(09)
Manufacturer Or Supplier:
BD Diagnostics Preanalytical Systems
Target Audience:
Hospital Managers / CEOs
Biomedical Engineers
Nursing Managers
Nursing Staff
Pharmacy Staff
ICU Staff
Public Health Nurses
Risk Managers
Clinical Directors
Purchasing Managers
Supplies Managers
Hospital Personnel
Hospice Personnel
Private Medical Practitioners
All Wards
Medical Device Distributors
Problem Or Issue:
BD Diagnostics Preanalytical Systems have received an increase in reports of blood leakage when using the BD Vacutainer® Multiple Sample Luer Adaptor. The blood leakage is attributed to the retractable non-patient cannula (grey) showing non sleeve-recovery, sleeve leakage or sleeve fall-off. BD has also received reports detailing blood leakage at the luer tip connection end, which has the potential to lead to evacuated blood collection tubes not being filled completely.
These issues can lead to an increased risk to users of exposure to blood and a risk of under-filling of blood collection tubes which could lead to unexpected results in some laboratory tests. No adverse incidents of accidental blood exposure or under-filling of the tubes involving the BD Vacutainer® Multiple Sample Luer Adaptor have been reported to the IMB.
Background Information Or Related Documents:
In May 2013, BD issued a Field Safety Notice (FSN) advising users of this issue and providing details of the affected lots. The FSN contained the following recommendations to relevant staff:
(1) To continue the use of universal/standard precautions (including appropriate personal protective equipment) to minimize the risk of blood exposure.
(2) To ensure that evacuated blood collection tubes meet the required fill-volume as indicated on the specific tube prior to processing.
In August 2013, BD issued a second FSN, providing details of additional lots of the BD Vacutainer® Multiple Sample Luer Adaptor, catalogue number 367300, that are potentially affected by this issue. The FSN now includes all lots falling within the range of lot number 1326169, expiry date 11/2014, to lot number 3072890, expiry date 03/2016, inclusively.
The circulation of this second FSN to the Irish market was delayed due to a communication error by BD. The updated FSN (see attached) was circulated to Irish users on the 21st February 2014.
BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300 Document
Actions To Be Taken:
he IMB advises that users:
(1) Identify affected lots and ensure that all relevant staff are aware of the recommended actions in the manufacturer’s FSN.
(2) Distribute this notice to healthcare professionals in your organisation who may use the BD Vacutainer® Multiple Sample Luer Adaptor (Product Ref: 367300) and maintain awareness of this safety notice for an appropriate time period.
(3) Complete and return the FSN acknowledgement to BD to indicate receipt and transmission of this FSN in your organisation.
(4) If you have distributed the devices to other healthcare professionals or organisations, forward this notice to those healthcare professionals and organisations.
(5) BD will replace products from affected lot numbers on request. Contact BD for replacement product, if required.
Further Information:
Enquiries to the manufacturer of the device should be addressed to:
Jonathan Fleet
Becton Dickinson and Company
The Danby Building
Edmund Halley Road
Oxford
OX4 4DQ
United Kingdom
Telephone: +44-1865-781529
Fax: +44-1865-781528
Email:
jonathan_fleet@europe.bd.com
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail:
devicesafety@hpra.ie
Website:
www.hpra.ie
Please click here to view a PDF version of this Safety Notice
Please click here to view the FSN
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Date Printed: 19/04/2024