FDA Approval for Prefilled Syringe with Needle Protection System

U.S. Market Launch: B. Braun Medical Inc. Uses Needle-Trap from Schreiner MediPharm for New Prefilled Heparin Syringe

B. Braun Medical Inc., located in Bethlehem, PA, recently launched its prefilled syringe of Heparin Sodium Injection, USP (United States Pharmacopeia; compendium of drug information) which utilizes Schreiner MediPharm’s label-integrated Needle-Trap system to the U.S. market. According to B. Braun, this is the first prefilled heparin syringe with an integrated needle protection device approved by the U.S. Food and Drug Administration (FDA).

In the United States, syringes should be used with safety devices to protect healthcare staff against the risk of needlestick injuries. B. Braun Medical was looking for an efficient and safe needle protection solution for its prefilled Heparin Sodium Injection and found it in Needle-Trap from Schreiner MediPharm.

The Needle-Trap system is internationally established. It complies with the US NIOSH requirements for safe instruments, among other things, and has been awarded 510(k) Pre-Market Notification by the FDA for marketing in the United States. “Clinical staff benefit from reliable protection against needlestick injuries because Needle-Trap’s activation is easy and irreversible. It is intuitive to use and requires no change in injection technique,” says Gene Dul, President of Schreiner MediPharm in the United States.

Needle-Trap is the only label-based needle protection system on the market: The plastic needle trap is an integral component of the marking label and serves to secure the needle after the injection has been performed. Due to its special construction, Needle-Trap can easily and cost-efficiently be integrated into existing pharmaceutical production processes. It requires only minor modifications of the application systems, no changes to secondary packaging, and minimal space during shipping, storage and disposal.

“Our products are designed to increase patient and clinician safety, while reducing medication errors and improving dosage accuracy and workflows. Obviously, efficient and economical manufacturing are equally important. Collaborating with Schreiner MediPharm allowed us to meet those needs,” says Leigh Nickens, Director of Marketing, Fluid Therapy and Injectable Drugs at B. Braun.

About B. Braun Medical
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.

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Prefilled syringes from B. Braun with Needle-Trap
The prefilled syringes from B. Braun with Schreiner MediPharm’s Needle-Trap are the first prefilled heparin syringes with an attached needle protection system approved in the US market.

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About Schreiner MediPharm

Schreiner MediPharm, a business unit of Schreiner Group GmbH & Co. KG based in Oberschleissheim near Munich, is a leading developer and manufacturer of innovative, multifunctional specialty labels and marking solutions with value-added benefits for the healthcare industry. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm is a highly capable development partner and reliable quality supplier to leading pharmaceutical and medical device technology companies worldwide.

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