BD 328418 – Syringe 1cc 31gx5/16″ U100 Ultra-Fine Insulin 100/Bx, 5 BX/CA

BD 328418 – Syringe 1cc 31gx5/16″ U100 Ultra-Fine Insulin 100/Bx, 5 BX/CA

BD Ultra-Fine Short Needle Insulin Syringes 1mL 8mm (5/16″) 31G

328418 – BD Insulin Syringes with the BD Ultra-Fine needle 8mm x 31G 1 mL/cc

BD 328418 Ultra-Fine Needle is a 31-gauge, 8mm (5/16″) syringe needle engineered to provide comfort, accuracy and ease in injecting. Reduces the risk of a painful injection in the muscle.

• Greater Efficacy: Efficacy equivalent to longer needles
• Patient Choice: Preffered by over 80% patients
• Less intimidating: Less intimidating for patients
• Reduced Risk: Reduces the risk of intramuscular injection
• Self-contained insulin syringe with permanent needle for use with U-100 insulin.
• Packaging contains end user directions and information.

Key Product Features

Needle length (mm)

Insulin needles come in different lengths. BD Original Needles are 12.7 mm (1/2″) long, and BD Short Needles are 8 mm (5/16″) long. The BD Nano Needle 4mm (3/16″) and BD Mini Needle 5mm (5/32″) are available only in pen needles. For a comfortable injection experience, shorter needle lengths are recommended and preferred.

Needle gauge (G)

The higher the gauge, the thinner the needle. For example, 32G is thinner than a 31G needle.Insulin needles are available in many gauges (G), or thicknesses. The higher the gauge, the thinner the needle. For example, a 32 G needle is actually thinner and more comfortable than a 29 G needle.

ThinWall

Thin Wall: As shown in the diagram, the thin wall needle has a narrower steel wall, allowing a greater volume of fluid to pass through it. The flow rate is typically equivalent to that of a needle one gauge larger. This is especially important with very thin needles.

Permanently Attached Needle

Most commonly found in insulin and ‘tuberculin’ syringes. Permanently attached needles, also known as integral needles, reduce the amount of medication waste and allow accurate mixing of different medications into one syringe.

Regulatory Compliance and Quality System

BD Products comply with the regulatory requirements of the region in which these are sold and manufactured.

Sterility

All products which are labeled as #sterile# and released for sale by BD are certified to be sterile per EN 556-1 Sterilization of Medical Devices as long as the package is unopened and undamaged. This product is sterilized via Cobalt 60 – Irradiation. Sterilization cycle development/validation is performed to 10-6 SAL in accordance with current ISO 11137 guidelines.

Biocompatability

This product has been evaluated in accordance with ISO 10993 “Biological Evaluation of Medical Devices”, and complies with all relevant sections.

Pyrogenicity

All products which are labeled as non-pyrogenic and released for sale by BD have been tested per United States Pharmacopeia (USP) chapter (85)- Bacterial Endotoxins Test and meets limits as specified in chapter 161- Transfusion and Infusion Assemblies and Similar Medical Devices.

Quality Control Testing and Release

Representative production samples are collected and inspected in accordance with current applicable product specifications. Inspection records are reviewed and signed off by qualified personnel for product release. The released devices meet applicable BD product specification(s).

Device Characteristics

Proper Injection Technique

Proper injection technique is essential to improve consistency in medication delivery and optimize glycemic control. It includes factors such as:

• knowing where the common injection sites are
• understanding how to rotate sites
• ensuring consistent delivery into subcutaneous (fat) layer
• choosing proper needle length
• avoiding injecting into muscle

Why is Proper Disposal Important?

Proper syringe disposal will help to:

• Store and safely dispose of used syringes and lancets,
• Protect trash collectors from accidental needlesticks,
• Prevent your used syringes from falling into the wrong hands,
• Protect the environment.

Product Packaging Information