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BD Micro Fine™ Plus U 100 1 mL Insulin Syringe with 29 30G x 12.7 mm Needle

BD Micro Fine™ Plus U 100 1 mL Insulin Syringe with 29 30G x 12.7 mm Needle

Becton Dickinson

Medical device – insulin syringe with fixed needle
  • CE Marked Class IIa medical device under the European Medical Devices Directive 93/42/EEC, with CE certificate number 252.140 issued by NSAI (Notified Body 0050).
  • Manufactured under an EN ISO 13485 Certified quality management system for medical devices (BD Medical – Diabetes Care sites registered under ISO 13485).
  • Complies with ISO 8537 for sterile single Use syringes, with or without needle, for insulin.
  • Sterilisation validated according to EN 556 1 for terminally sterilised medical devices designated as sterile.
  • Gamma radiation sterilisation process validated in accordance with EN ISO 11137 1 and EN ISO 11137 2 for development, validation and routine control of radiation sterilisation.
  • Microbiological testing and sterility validation performed in line with EN ISO 11737 1 and EN ISO 11737 2 for determination of bioburden and sterility testing.
  • Biocompatibility of materials assessed in accordance with applicable ISO 10993 standards for devices in contact with body fluids and tissues for limited periods.
  • Labelled as latex Free and non Pyrogenic, supporting compliance with regulatory and industry guidelines to minimise allergic and pyrogenic reactions.
Disposable U-100 insulin syringe, 1 mL, with permanently attached 29G x 12.7 mm needle

Description

The BD Micro-Fine™ Plus U-100 1 mL Insulin Syringe with 29G x 12.7 mm needle is a sterile, single-use, latex-free insulin delivery device designed for the subcutaneous administration of U-100 insulin in the treatment of diabetes mellitus. Each syringe has a clear polypropylene barrel with black U-100 unit graduations up to 1 mL (100 units) and a permanently attached 29G (0.33 mm) x 12.7 mm stainless steel needle. The needle features BD’s precision point geometry and Micro-Bonded lubrication for smooth insertion and injection comfort. The syringe includes a polystyrene plunger rod with an elastomer stopper to ensure a secure seal and controlled plunger movement, while the orange needle shield and printed scale distinguish it as a U-100 insulin syringe. The product is supplied as blister-packed, self-contained syringes with an orange needle shield, with 200 units per box (reference 324891) and is suitable for use by patients or healthcare professionals in home, hospital or clinic settings.

Bnefits

  • Designed specifically for U-100 insulin delivery with a 1 mL (100 unit) capacity and clearly printed U-100 unit graduations to support accurate dosing.
  • Permanently attached 29G x 12.7 mm needle reduces dead space compared with detachable needle systems and helps minimise insulin wastage.
  • Fine 29G (0.33 mm) needle and BD’s precision point geometry help provide comfortable subcutaneous injections for people with diabetes.
  • Micro-Bonded needle lubrication improves smoothness of insertion and withdrawal, enhancing injection comfort.
  • Sterile, single-use and latex-free construction supports infection prevention and reduces the risk of latex-associated allergic reactions.
  • Clear polypropylene barrel with high-contrast black scale markings allows easy visual inspection of insulin volume and air bubbles.
  • Self-contained, blister-packed syringes with orange needle shield and scale mark aid quick identification as U-100 insulin syringes.
  • Manufactured and quality-controlled under an ISO 13485-certified quality management system, with 100% needle point inspection to assure consistent high quality.
  • Gamma-sterilised with validated processes to achieve an appropriate sterility assurance level and a typical shelf life of 5 years from sterilisation.
  • Suitable for both patient self-administration and professional use in home, clinic and hospital environments, supporting broad clinical application in diabetes care.

Indications

  • Subcutaneous administration of U-100 insulin in patients with diabetes mellitus.
  • Parenteral administration of other physician-prescribed U-100 insulin formulations where a 1 mL insulin syringe with 29G x 12.7 mm needle is clinically appropriate.
  • Use by adult patients or caregivers trained in insulin self-injection, and by healthcare professionals in home, ambulatory, clinic or hospital settings.
  • Situations requiring accurate measurement and delivery of insulin doses up to 1 mL (100 units) using a dedicated insulin syringe with fixed needle.

Composition

  • Cannula: Surgical-grade stainless steel hypodermic tubing, 29G, 12.7 mm length.
  • Cannula lubricant: Silicone-based lubricant on the needle for smoother insertion.
  • Barrel: Transparent medical-grade polypropylene.
  • Barrel lubricant: Medical-grade silicone oil on the inner barrel wall to facilitate smooth plunger movement.
  • Needle hub: Polypropylene, permanently bonded to the syringe barrel (fixed needle).
  • Adhesive (needle bonding): Ultraviolet-curing adhesive or oven-cure epoxy used to bond the cannula to the hub (for 1 mL syringes).
  • Plunger rod: Polystyrene, designed for comfortable thumb grip and controlled advancement.
  • Stopper (piston): Polyisoprene or styrene-butadiene rubber (SBR) for 1 mL syringes, providing a tight seal and smooth movement.
  • Shield: Polyethylene cap with orange colourant for U-100 insulin identification.
  • Plunger cap (for self-contained syringes): Polyethylene.
  • Latex status: Product is latex-free; natural rubber latex is not used in the materials formulation.

Formulation

  • Device type: Sterile, single-use U-100 insulin syringe with permanently attached hypodermic needle.
  • Reference: 324891 (U-100 insulin syringe, blister pack).
  • Nominal volume: 1 mL (100 units of U-100 insulin).
  • Scale: Black printed U-100 insulin unit graduations up to 100 units (1 mL).
  • Needle gauge and length: 29G (0.33 mm outer diameter) x 12.7 mm (1/2 inch).
  • Needle tip: Bevelled hypodermic needle tip with precision point geometry.
  • Needle shield: Orange colour needle shield indicating U-100 insulin syringe.
  • Configuration: Self-contained, sterile interior with pre-attached needle and protective needle shield.
  • Sterilisation method: Gamma radiation (radiation sterilisation) with validated process.
  • Shelf life: 5 years after sterilisation when stored in accordance with manufacturer instructions.

Packaging

  • Primary pack: Self-contained, individually sterile blister packs with orange needle shield and printed scale mark.
  • Shelf box contents (reference 324891): 200 individually packaged 1 mL, 29G x 12.7 mm U-100 insulin syringes.
  • Shipping configuration: Shipping box contains blisters as specified for reference 324891 (200 units per shipping box).
  • Labelling: Packaging labelled with product reference, volume, needle gauge and length, U-100 designation, lot number, expiry date, sterilisation method and latex-free status.
  • Outer cartons: Printed cardboard cartons designed to protect syringes from mechanical damage and environmental contamination during storage and transport.

Usage

  • Check the expiry date and integrity of the sterile blister pack; do not use if the packaging is damaged, opened, or past the expiry date.
  • Wash hands and prepare the insulin vial or penfill according to the insulin manufacturer’s instructions and local diabetes care guidelines.
  • Remove the syringe from the blister pack aseptically and remove the orange needle shield without contaminating the needle.
  • If required, draw air into the syringe equal to the prescribed insulin dose, then insert the needle into the insulin vial and inject the air into the vial to facilitate withdrawal (according to local protocol).
  • Invert the vial and syringe together and slowly pull back the plunger to draw the prescribed dose, aligning the plunger tip with the appropriate unit marking on the U-100 scale.
  • Remove any visible air bubbles by gently tapping the barrel and expelling air back into the vial, then re-adjust the plunger to the correct dose marking.
  • Select and prepare the injection site (e.g., abdomen, thigh, upper arm) according to clinical guidance, rotating sites as recommended to reduce lipodystrophy risk.
  • Insert the needle subcutaneously at the recommended angle (typically 90° or 45° depending on needle length, patient body habitus and local protocol) and inject the insulin slowly and steadily by depressing the plunger fully.
  • Hold the needle in place for a few seconds after completion of the injection to ensure full dose delivery, then withdraw the needle from the skin.
  • Immediately discard the used syringe, with needle attached, in an appropriate sharps container; do not recap, bend, break, or reuse the needle or syringe.
  • Do not attempt to sterilise or reuse the device; it is designed and validated for single use only.
  • Follow local, national and diabetes-care-specific guidelines for insulin handling, dose calculation, injection technique, and sharps disposal.

Contraindications

  • Do not use if the sterile package is damaged, opened or contaminated, or if the product is past its expiry date.
  • Do not reuse, reprocess or resterilise the syringe; reuse may result in infection, needle blockage, inaccurate dosing or device failure.
  • Do not use if the needle is visibly bent, blunted, corroded or otherwise damaged, or if the barrel or plunger shows cracks or deformation.
  • Not suitable for insulin concentrations other than U-100 unless specifically validated and dose adjustments are clearly understood; using U-100 syringes with other concentrations can result in dosing errors.
  • Do not use for intravenous, intramuscular or intrathecal injection unless specifically directed by a healthcare professional and consistent with clinical guidance (device is intended primarily for subcutaneous use).
  • Avoid use in individuals with known hypersensitivity to any of the device materials if such sensitivity has been clinically identified, although the product is latex-free.
  • Do not share syringes between patients, even if the needle appears unused or is changed, as this may transmit bloodborne pathogens.

Adverse Effects

  • Local injection-site reactions such as pain, redness, bruising, itching or swelling, generally related to the insulin and injection technique rather than the syringe design.
  • Lipohypertrophy or lipoatrophy at injection sites when injection site rotation is inadequate, primarily due to insulin effect rather than the device itself.
  • Bleeding or haematoma formation at the injection site, particularly in patients with coagulation disorders or on anticoagulant therapy.
  • Risk of infection or abscess at the injection site if aseptic technique is not followed or if syringes are reused contrary to instructions for use.
  • Rare risk of needle breakage if the needle is bent or mishandled during injection.
  • Potential needle-stick injuries to patients or others if sharps are not handled and disposed of correctly.
  • Systemic adverse effects (e.g., hypoglycaemia, hyperglycaemia, allergic reactions) related to insulin dosing, insulin formulation or injection errors, which are due to the medicinal product or incorrect use rather than the syringe itself.

Storage Conditions

  • Store syringes in their original packaging in a clean, dry environment.
  • No special storage conditions are required; normal room temperatures within the range specified by the manufacturer are suitable.
  • Avoid excessive heat, direct sunlight and high humidity that could compromise packaging integrity or material performance.
  • Protect from mechanical damage, crushing or bending of cartons that may affect needle straightness or packaging.
  • Keep out of reach of children and unauthorised users.
  • Do not use the product after the expiry date printed on the packaging (typical shelf life is 5 years after sterilisation).

Duration

The syringe is a single-use device intended for one episode of insulin preparation and injection only; the overall duration of treatment is determined by the patient\u2019s insulin regimen, not by the device itself.

Onset

Not applicable to the device; the onset, peak and duration of effect depend on the specific insulin formulation, dose, injection site and patient factors, rather than on the syringe.

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