BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(09)

2014-02-28

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bd-vacutainer-multiple-sample-luer-adaptor.-catalogue-number-367300&id=bc77f825-9782-6eee-9b55-ff00008c97d0

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.

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.