B Braun 612138 - 6F 3-Piece Introducer Set with Echogenic Trocar Needle, Guidewire 0.018" x 60cm, NT Mandrel, AU Coil, 10/CS (Rx)

B Braun 612138 - 6F 3-Piece Introducer Set with Echogenic Trocar Needle, Guidewire 0.018" x 60cm, NT Mandrel, AU Coil, 10/CS (Rx)

The B Braun 612138 3-Piece Introducer Set is designed for precision and reliability in interventional medical procedures, providing healthcare professionals with the tools necessary for accurate vascular or organ access. This set includes:

• 6F Introducer Sheath (20cm): Facilitates the smooth insertion of medical devices such as catheters, guidewires, and other diagnostic tools.
• 21G x 15cm Echogenic Trocar Needle: The needle is equipped with echogenic properties, improving visibility during ultrasound-guided procedures for accurate placement.
• 0.018" x 60cm Guidewire: Provides the flexibility and maneuverability needed to navigate complex vascular pathways and assist with the placement of other medical devices.
• NT Mandrel with AU Coil: The non-thermal (NT) mandrel is made from durable PTFE material, ensuring flexibility and kink resistance, while the AU Coil provides added strength and stability during use.

This versatile introducer set is ideal for use in diagnostic and therapeutic procedures, including catheter insertion, biopsies, and drainage, providing enhanced precision and ease of use.

Key Benefits

The B Braun 612138 introducer set offers numerous benefits that improve the safety, accuracy, and efficiency of medical procedures:

• Echogenic Needle for Enhanced Visibility: The 21G x 15cm Trocar needle features echogenic properties, making it highly visible under ultrasound guidance, ensuring precise placement in challenging anatomical areas.
• Superior Flexibility and Durability: The 0.018" x 60cm guidewire is flexible, allowing it to navigate complex vascular pathways with ease. The PTFE-coated NT Mandrel and AU Coil enhance durability, preventing kinking and ensuring reliable performance throughout the procedure.
• Single-Use Sterile Design: The set is designed for single-use only, reducing the risk of cross-contamination and infection during procedures.
• Smooth and Easy Insertion: The 6F introducer sheath ensures smooth passage for the guidewire and catheter, minimizing patient discomfort and insertion trauma.

Compatibility and Applications

The B Braun 612138 introducer set is compatible with a variety of medical devices, including diagnostic catheters, biopsy needles, and drainage tubes. Its flexible guidewire and echogenic needle make it particularly effective in procedures that require precise needle placement and ultrasound guidance.

Common applications include:

• Vascular Access: For procedures such as angiography, central venous access, and catheter placement.
• Biopsy Procedures: Facilitating the precise placement of biopsy needles in organs that require ultrasound-guided access.
• Drainage Procedures: Assisting with the drainage of fluids from specific organs or anatomical areas.

The echogenic properties of the Trocar needle make it particularly useful for accessing difficult-to-reach areas with improved accuracy and safety.

Usage Guidelines

To ensure proper use of the B Braun 612138 introducer set:

• Sterile Technique: Handle the set using sterile techniques to prevent contamination and ensure a safe procedure.
• Ultrasound Guidance: Use the echogenic Trocar needle with ultrasound guidance for precise needle placement.
• Smooth Insertion: Carefully insert the introducer sheath to allow for smooth passage of the guidewire or catheter.
• Proper Disposal: As the set is single-use, it must be properly disposed of after each use in accordance with healthcare facility protocols for sharps disposal.

Refer to the manufacturers guidelines for additional instructions and safety protocols.

Certifications, Safety Standards, and Regulatory Approvals

The B Braun 612138 introducer set meets FDA and CE regulatory standards, ensuring it complies with the necessary safety and performance requirements. The FDA approval guarantees that the product has met stringent medical device regulations in the United States, while the CE Mark indicates compliance with European Union medical device standards. Additionally, the product adheres to ISO 13485 quality management systems, ensuring consistency and quality in manufacturing.

Comparison with Competitor Products

The B Braun 612138 introducer set stands out from its competitors for several key features:

• Echogenic Needle: Unlike many other introducer sets, the B Braun 612138 includes an echogenic Trocar needle that enhances visibility under ultrasound guidance, making it easier for healthcare professionals to place the needle accurately.
• Flexibility and Durability: The 0.018" x 60cm guidewire provides greater flexibility and maneuverability than many competitor products, which can improve the ease and accuracy of catheter or device placement. Additionally, the PTFE coating and AU Coil in the NT Mandrel increase durability and prevent kinking, ensuring reliable performance during complex procedures.
• Single-Use Design: Like most high-quality introducer sets, the B Braun 612138 is designed for single-use, which reduces the risk of cross-contamination and ensures patient safety.

Typical User Profile and Application Scenarios

The B Braun 612138 introducer set is designed for use by:

• Radiologists: Who perform ultrasound-guided procedures, such as biopsies and catheter insertions.
• Interventional Surgeons: Who require precise vascular access for therapeutic procedures.
• Medical Technicians: Who assist in the setup and execution of interventional medical procedures.

It is commonly used in hospitals, surgical centers, and outpatient clinics where safe and accurate access to blood vessels or organs is required for diagnostic and therapeutic procedures.

Best Practices for Use and Maintenance

To ensure the optimal performance and safety of the B Braun 612138 set:

• Use Ultrasound Guidance: Always use the echogenic Trocar needle with ultrasound guidance to ensure accurate placement.
• Sterile Handling: Handle all components of the set with sterile techniques to avoid contamination and ensure patient safety.
• Proper Disposal: Dispose of the entire set in a sharps container following single-use to maintain a safe environment for healthcare professionals and patients.
• Avoid Excessive Force: Avoid using excessive force during insertion, which could cause tissue trauma or damage to the components of the set.

Regulatory and Safety Information

The B Braun 612138 set is manufactured in compliance with FDA and CE regulations, ensuring that it meets all necessary safety standards for medical use. It has also been designed under ISO 13485 guidelines to ensure continuous quality and reliability in its manufacturing process.

How to Order

To order the B Braun 612138 3-Piece Introducer Set, simply add the product to your cart on the CIA Medical website and proceed to checkout. For bulk orders or further inquiries, please contact CIA Medical customer service at (312) 275-5850 or use the contact form available on the website. Our team is ready to assist with any questions or special requests regarding your order.