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 041 06 13 000
Date submitted:	6/9/2013

Manufacturer:	P3 Medical Ltd
Device Type:	Ventilation tube , Vented Tracheal Tube Guides (Bougies),
Description:	Vented Tracheal Tube Guides (Bougies) to reduce the risk of cross infection
Medical Device Identifier:	All the Tracheal Tube Bougie Vented, 14 ch x 750mm with the lot number 441089
Reason of Field Safety Corrective Action:	Small quantity (batch of 300 pieces) of the lot number 441089 has a defect where the punched eyes of the tracheal tube guide for ventilation was not “punched”. This could lead to the loss of airway to the patient where the Bougie is being used to maintain the airway
Remedy Action:	Discontinue the use of all affected product with immediate effect. Where possible return all affected product to your main stores and segregate it to awaiting collection by P3 Medical Ltd / Distributer
Athorized Representative/Importer/Distributor:	Medical Oasis International , Riyadh , (011) 4037000
Report Source:	NCMDR
Source Ref. Number:	9691F15B8E301
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:	P3 Medical Ltd..pdf

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