SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 133 05 18 000
Date submitted:	5/30/2018

Manufacturer:	Becton, Dickinson And Company
Device Type:	BD SmartSite Administration Sets
Description:	Infusion Pump Administration Sets
Medical Device Identifier:	10015489, 11426965, 2120-0500, 2420-0007, 2420-0500
Reason of Field Safety Corrective Action:	BD states that it has received reports of users experiencing difficulty or failing to prime the above administration sets. The pump administration sets require priming before patient use as described in the directions for use. BD also states that it is during the priming process that this problem can be observed. During priming, when attempting to fill the drip chamber, the drops into the drip chamber will not be observed once the roller clamp is opened. BD further states that this problem is highly detectable.
Remedy Action:	Identify any affected product in your inventory. If you have affected product, verify that you have received this notice with BD. Follow the instructions in the letter to the problem during priming.
Athorized Representative/Importer/Distributor:	Medical Regulations Gate
Report Source:	NCMDR
Source Ref. Number:	A30552, A30552 01, FD6C12AD18240
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	BD.pdf

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