C.R. Bard LH-0037YN - SafeStep Huber Needle Set with Y-Injection Site and Medegen Needleless Injection Cap, 20 Gauge x .5", 25/CS

C.R. Bard LH-0037YN - SafeStep Huber Needle Set with Y-Injection Site and Medegen Needleless Injection Cap, 20 Gauge x .5", 25/CS

The SafeStep Huber Needle Set is designed with the clinician and the patient in mind. The textured handle is easy to grasp and rotates to enable maneuvering and positioning of tubing to enable comfortable and proper site dressing. Also the small footprint helps minimize dressing materials while the clear plastic base allows clinicians to view and inspect the insertion site throughout the course of therapy.

• Rotating needle head for maneuvering and positioning.
• Small stable design ideal for patient comfort and easy to dress.
• Wingless design.
• Low Profile (0.550").
• Padded footprint for comfort.
• Dual lumen port adaptable.

Safety Mechanism

The safety mechanism is housed in the plastic base. Once the needle has been pulled through the base the mechanism covers the needle point and locks it into the plastic base. The safety mechanism protects clinicians and patients from accidental needlestick injuries during needle removal, transport and disposal of the SafeStep needle.

Features and Benefits

• Stable needle base for patient comfort during dressing.
• Wingless design for site care.
• Dual lumen port compatible to enable simultaneous infusions through dual lumen ports.
• Audible "click" and visual indication of lockout to ensure safety device has been activated.
• Safety feature conforms to current user technique.
• Safety feature covers needlepoint to reduce risk of injury and exposure to bloodborne pathogens.

Comfortable for the Patient

• Smallest footprint of all Bard Safety Infusion Sets.
• Non-absorbant patient comfort pad.
• Improved dressing profile.
• Lower insertion and penetration force than other port access needles.

Indications For Use

The SafeStep Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep Huber Needle safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.

Cautions

• Care must be taken to avoid accidental needle sticks.
• Only qualified health care practitioners should insert, manipulate and remove these devices.
• Carefully read all instructions prior to use.
• Follow all instructions, contraindications, warnings, cautions and precautions for all infusates, ports, IV pumps, IV sets and needleless systems, as specified by the CDC (USA) or local equivalent.
• Do not use this product if it appears damaged or if the package has been previously opened or damaged.
• Federal law restricts the device to sale by or on the order of a physician. High pressure or use with power injectors may cause leakage or damage.
• Confirm correct needle placement in the port reservoir by aspiration of blood before infusion of any substance. If there is doubt regarding proper needle placement, perform a radiographic dye procedure to confirm placement per institutional protocol.
• Do not remove and reinsert the needle into the port.
• Avoid excessive manipulation once the needle is in the port.
• Do not access the needleless Y-injection site valve with a needle. Valve puncture may result in an embolism.

MR Information

Non-clinical testing has demonstrated the device is MR conditional. It can be scanned safely under:

• Static magnetic field of 3 tesla or less.
• Maximum specific absorption rate (SAR) of 4 W/kg for 15 minutes of scanning.
• Spatial gradient field of 360 Gauss/cm or less.

In non-clinical testing, the SafeStep Huber Needle Set produced a temperature rise of less than 1.6 C at a maximum whole body average specific absorption rate (SAR) of 4 W/kg, as assessed by calorimetry for 15 minutes of MR scanning in a 3 Tesla Siemens Trio using software version VB15.

For minimal Image Artifact

• MR image quality may be compromised if the area of interest is within the distance, specified in Table 1, to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

Frequently asked questions

1. How can I prevent the safety mechanism from sliding down the needle during port access?

Hold only the handle with your thumb and index finger, or with three fingers hold the A handle and base during port access. Avoid pushing down on the base of the product.

2. Can I use the Bio-Patch dressing with SafeStep Huber Needle Set and/or PowerLoc MAX Power Injectable Infusion Set?

Yes, the Bio-Patch dressing can be easily slipped between the skin and the Huber needle sets smooth plastic base. (Another option is to clip the slit of the Bio-Patch onto the shaft of the Huber needle sets needle, being careful to keep the Bio-Patch dressing off center on the needle. Once the needle is in the port the Bio-Patch dressing can be centered around Huber needle sets needle.

3. If the SafeStep Huber Needle Set and/or PowerLoc MAX Power Injectable Infusion Set base is not flush with the skin, may I lower the base to the skin so as to better dress the Huber needle set?

Yes, if the needle is fully seated in the port and there is a gap between the Huber needle sets base and the skin, you may lower the base to the skin.

4. We use dual lumen ports. Can I use the SafeStep Huber Needle Set and/or PowerLoc MAX Power Injectable Infusion Set with dual lumen ports?

Yes, the Huber needle set may be used with dual lumen ports. For convenience, turn the Huber needle set base 90 so that both tubing sets are aligned on the same.

5. If I would like to tape down the infusion set before placing the transparent dressing over the access site, are there recommendations?

Yes, an H-tape or X-tape are examples that may be used as additional securement to a transparent dressing.

6. Do you have any suggestions for dressing the SafeStep Huber Needle Set and/or PowerLoc MAX Power Injectable Infusion Set?

Dress the Huber needle set according to your institutional guidelines. Select the appropriate needle length. Use a single occlusive dressing large enough to completely cover the site and any dressing materials.