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 004 11 15 001
Date submitted:	11/8/2015

Manufacturer:	B Braun Medical Inc
Device Type:	A/V Set DEHP-free PVC for Dialog
Description:	Dialysis, A/V Set
Medical Device Identifier:	Art. No. 7211034 Batch # 15C20980 …………………………… BfArM update code : 7211032 : 15C16980 7211033 : 15C23980 7211035 : 15C16980 7210868 : 15D27880
Reason of Field Safety Corrective Action:	During continuous post-market surveillance we became aware of a disconnection of the female Luer-Lock connector from the venous side of the Single-Needle adapter leading to blood loss for the patient.
Remedy Action:	-Check whether you have above mentioned products in stock, and quarantine them. The isolated products will be exchanged according to your information on the fax form. -At the next delivery the quarantined products will be exchanged according to your information given on the return fax
Athorized Representative/Importer/Distributor:	Medical supplies & Services Co.Ltd Mediserv
Report Source:	BfArM
Source Ref. Number:	7419/15
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	B. Braun Avitum AG.pdf

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