C.R. Bard 631910 - MiniLoc Safety Infusion Set without Y-Injection Site, 19 Gauge x 1", 20/CS

C.R. Bard 631910 - MiniLoc Safety Infusion Set without Y-Injection Site, 19 Gauge x 1", 20/CS

The MiniLoc Safety Infusion Sets low profile and small footprint design make it the ideal needle for dressing the access site. The small size of the needle and the downward angle of the tubing coming off of the back of the device help to maintain dressing integrity.

A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system, typically via an implanted injection/infusion port. It typically includes a needle that has a lateral hole (side-hole), tubing, connectors, chambers, and clamps. This is a single-use device.

• Small footprint ideal for dressing.
• Low profile.
• Light weight.
• Site visibility.
• Dual lumen port compatible.

Features and Benefits

• Low profile and small footprint enable the site to be easily dressed.
• Downward angled tubing to help maintain dressing integrity.
• Audible, tactile and visual click to confirm engaged safety mechanism.
• Dual lumen port adaptable to enable simultaneous infusions.
• Safety feature covers needlepoint to reduce risk of injury and exposure to bloodborne pathogens.

Safety Mechanism

As the needle is removed from the port and enters the base of the needle an orange safety shield rotates over the needle point and locks the needle into place. A tactile feel, audible click and visual confirmation verify the engaged safety mechanism for safe removal, transporting and disposal of the MiniLoc needle.

Indications For Use

This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. This product utilizes a non-coring right angle Huber needle and is available with and without an adaptable Y-site which will accommodate the addition of a needleless access or standard injection port. This product is a sterile, non-pyrogenic, single use device. It is recommended that this product be changed in accordance with U.S. Centers for Disease Control (CDC) guidelines for administration sets, local or country specific guidelines, professional standards of practice, and/or according to your institutions policy for Huber needle IV administration sets.

FAQ

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

Usually this is caused by pressing on the safety device during access. To prevent this, it is recommended to hold the safety infusion sets wings together with the thumb and index finger during port access. (This will engage the molded stabilization notch in the interior of the wings.)

2. Can I use the Bio-Patch dressing with the MiniLoc Safety Infusion Set and/or the PowerLoc Safety Infusion Set?

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

3. If the MiniLoc Safety Infusion Set and/or the PowerLoc Safety Infusion Set base is not flush with the skin, may I lower the base to the skin so as to better dress the safety infusion set?

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

4. We use dual lumen ports. Can I use the MiniLoc Safety Infusion Set and/or the PowerLoc Safety Infusion Set with dual lumen ports?

Yes, the safety infusion set is designed to work with dual lumen ports. It is okay to overlap the safety infusion sets movable wings to align the tubing on one side.

5. The MiniLoc Safety Infusion Set and/or the PowerLoc Safety Infusion Sets base is not flush with the skin. Are there recommendations for stabilizing the device?

Yes, if the needle is fully seated in the port and there is a gap between the safety infusion sets base and the skin, you may lower the base to the skin, and if institutional protocol allows, support the infusion set with gauze.

6. 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

7. Are the MiniLoc Safety Infusion Set and PowerLoc Safety Infusion Set MRI compatible?

Yes. Non-clinical testing has demonstrated the device is MR conditional. It can be safely scanned 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 PowerLoc Safety Infusion Set produced a temperature rise of less than 1.2 degrees C at a maximum whole body averaged 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 VA25.

Warnings!

• Fully tighten all connectors, Y-site end caps, or needleless connectors before using. Failure to attach an end cap after removing the male Luer locking end cap can result in an air embolism or bleeding.
• This is a single-use product. DO NOT REUSE. DO NOT RESTERILIZE.
• Failure to use this device correctly when removing needle from port site could result in the needle tip re-emerging from the base, resulting in an accidental needlestick with a contaminated needle. A needlestick with a contaminated needle may cause infectious disease.
• Verify needle length is correct based on port reservoir depth, tissue thickness, and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion; if too short, needle may not completely pierce port septum, and medication may be delivered into surrounding tissue and/or needle may be blocked.
• Handle and discard in accordance with accepted medical practice and all applicable regulations. After use, this product is a potential biohazard.
• Do not alter this device.
• Needleless Y-injection site valve may leak slightly at certain pressures resulting in a small bead of fluid on the valve.
• The textured handle and base are not connected. The base will move along the length of the needle.