Devices FDA

 News Release - October 19, 2011

Safety to the Power of Three: B. Braun Medical Inc. Announces Introcan Safety(R) 3 Closed IV Catheter

FDA Grants 510(k) Clearance for Introcan Safety® 3

BETHLEHEM, Pa., Oct. 19, 2011 -- (Healthcare Sales & Marketing Network) -- Expanding its offering of passive safety devices to protect both clinicians and patients from needlestick injuries (NSIs), B. Braun Medical Inc. (B. Braun) recently announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance of the company's Introcan Safety® 3 Closed IV Catheter, the next generation of B. Braun's Introcan Safety® IV Catheter. B. Braun made the announcement during the Association for vascular access 2011 Annual Scientific Meeting in San Jose, Calif., in early October.

"Recent research(1) confirms passive safety engineered devices are most effective for needlestick injury prevention," said Tom Sutton, Vice President, vascular access and IV Systems for B. Braun Medical Inc. "The Introcan Safety® 3 is designed to provide clinicians with not only an effective passive needlestick safety device, but also an added layer of safety and control with a bidirectional blood control valve to aid in the prevention of blood exposure each time the device is accessed."

The Introcan Safety® 3 features all elements of B. Braun's existing and proven Introcan Safety® IV Catheter. From insertion to advancing the catheter to needle removal, the Introcan Safety® 3 is designed to help protect clinicians and patients from NSIs as the device cannot be bypassed or activated inadvertently.

B. Braun's Introcan Safety® 3 will provide protection through:

• Passive Safety Needle Shield to aid in the prevention of NSIs
• Multiple Access Blood Control Valve to aid in the prevention of blood exposure
• Integrated Stabilization Platform to improve catheter stability and minimize movement within the vessel

For more information, please visit: Introcan Safety® 3 Closed IV Catheter, www.introcansafety.bbraunusa.com, or call 800-227-2862.
   

(1) Needlestick Injury Rates According to Different Types of Safety-Engineered Devices: Results of a French Multicenter Study conducted by GERES (Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux), and published by Infection Control and Hospital Epidemiology, April 2010; 31:402-407

About B. Braun

B. Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally-friendly focus. Guided by the company's "Sharing Expertise®" philosophy, B. Braun addresses the critical issues of infection prevention, medication safety and environmental responsibility by promoting best practices that help clinicians reduce medication errors, prevent healthcare-acquired infections (HAIs) and achieve sustainability objectives.

Consistently recognized by Frost & Sullivan and KLAS for its medical technology and support services, B. Braun employees share their knowledge with colleagues and customers to improve working processes in hospitals and medical practices and to enhance the safety of patients and healthcare professionals. For more information, call 800-227-2862, e-mail us at inquiry.us@bbraun.com or visit B. Braun at www.bbraunusa.com.

Source: B. Braun Medical

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