Description

The Gripper Plus™ Safety Port Access Needle by Smiths Medical MD, Inc. is a specialized medical device engineered for secure and efficient vascular access to implanted ports. This sterile, non-coring Huber needle is particularly suited for administering medications such as chemotherapy, antibiotics, and total parenteral nutrition (TPN). Designed for scenarios where the needle remains in the port for extended periods, it emphasizes both patient comfort and healthcare provider safety.

Safety Features

• Integrated Safety Mechanism: The needle features a safety arm that activates with an audible click and visible confirmation upon removal, significantly reducing the risk of needlestick injuries. This mechanism aligns with the NIOSH/CDC recommended safety criteria and supports a "hands behind the needle" technique, requiring minimal changes to standard clinical practices.

Design and Comfort

• Patient Comfort: Equipped with a thick, cushioned platform and a removable contoured grip, the needle ensures precise insertion and enhanced comfort. A chassis sponge further contributes to patient ease.

Needle Specifications

• Non-Coring Design: The needle's special tip design prevents rubber fragment contamination, and it is available in both straight and curved versions to accommodate various medical needs.

Tubing and Connectors

• Material and Configuration: The device includes medical-grade PVC extension tubing with a variety of connector options, such as luer connectors and needleless access connectors. Color-coded clamps and removable injection caps provide additional configuration flexibility.

Material Composition

• Construction: Made from 304 stainless steel and brass, the needle is latex-free and contains no heavy metals or recycled materials. It is compatible with medications like Taxol and lipid-based solutions.

Pressure and Power Injection

• High Pressure Resistance: The standard version withstands pressures up to 325 PSI, while the Power P.A.C. variant supports power injection up to 5 mL/sec and 300 PSI, featuring blue tubing and printed clamps for easy identification.

Sterility and Packaging

• Single-Use Design: Each needle is supplied sterile and intended for single use, with packaging that includes 12 units per box. The packaging is environmentally considerate, using only cardboard and paper materials.

Regulatory Compliance

• Certifications: The device is CE marked (Class IIa) and complies with MDR 2017/745, USA FDA 510K, and relevant ISO standards. It has a positive evaluation for Aseptic Non Touch Technique (ANTT®).

Available Sizes

• Gauge and Length Options: Available in gauges 19G, 20G, and 22G, with lengths ranging from 0.625" to 1.25". Configurations include options with or without Y-site and various extension sets.

Disposal and Environmental Considerations

• Waste Handling: The device should be disposed of in accordance with local medical waste regulations, ensuring safe and responsible handling post-use.