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


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 
OX4 4DQ 
United Kingdom 

Telephone: +44-1865-781529 
Fax: +44-1865-781528 

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 

Please click here to view a PDF version of this Safety Notice

Please click here to view the FSN

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