BD AutoShield Duo Pen Needle 0.30mm (30G) x 5mm Pack of 100

Becton Dickinson

Medical device – safety insulin pen needle

Safety-engineered insulin pen needle, 30G x 5mm, for pen injector devices

CE Marked medical device: BD AutoShield Duo pen needles are CE certified by National Standards Authority of Ireland (NSAI), notified body number 0050, with CE certificate number 252.783.
EU medical device classification: Class IIa medical device under Medical Devices Directive 93/42/EEC for BD AutoShield Duo pen needles.
Manufacturing quality system: Manufacturer and manufacturing sites registered to EN ISO 13485 and EN ISO 9001 quality management system standards for medical devices.
Sterilisation validated according to EN 556 1, EN ISO 11137 1 and EN ISO 11137 2 for radiation Sterilised medical devices.
Microbiological and sterility testing in accordance with EN ISO 11737 1 and EN ISO 11737 2.
Cannula and needle performance compliant with ISO 9626 (stainless steel tubing for medical devices) and ISO 11608 2 (needle Based injection systems for medical use – needles).
Sharps injury protection features compliant with EN ISO 23908 (sharp injury protection – requirements and test methods for sharps protection features for single Use hypodermic needles and related devices).
Latex Free device: explicitly stated as not containing natural rubber latex in the manufacturer’s technical data sheet.

CE Marked medical device: BD AutoShield Duo pen needles are CE certified by National Standards Authority of Ireland (NSAI), notified body number 0050, with CE certificate number 252.783.
EU medical device classification: Class IIa medical device under Medical Devices Directive 93/42/EEC for BD AutoShield Duo pen needles.
Manufacturing quality system: Manufacturer and manufacturing sites registered to EN ISO 13485 and EN ISO 9001 quality management system standards for medical devices.
Sterilisation validated according to EN 556 1, EN ISO 11137 1 and EN ISO 11137 2 for radiation Sterilised medical devices.
Microbiological and sterility testing in accordance with EN ISO 11737 1 and EN ISO 11737 2.
Cannula and needle performance compliant with ISO 9626 (stainless steel tubing for medical devices) and ISO 11608 2 (needle Based injection systems for medical use – needles).
Sharps injury protection features compliant with EN ISO 23908 (sharp injury protection – requirements and test methods for sharps protection features for single Use hypodermic needles and related devices).
Latex Free device: explicitly stated as not containing natural rubber latex in the manufacturer’s technical data sheet.

Safety-engineered insulin pen needle, 30G x 5mm, for pen injector devices

Description

BD AutoShield Duo Pen Needle 0.30mm (30G) x 5mm is a sterile, single-use, latex-free, safety-engineered insulin pen needle with dual automatic protective shields at both the patient and pen ends. The 5mm, 30-gauge needle is designed for subcutaneous injection of drugs using compatible pen injector devices, providing automatic front- and back-end needle shielding after use to help reduce the risk of accidental needlestick injuries and exposure to bloodborne pathogens while supporting accurate, comfortable insulin delivery.

Bnefits

Dual automatic protective shields that lock over both the patient-end and pen-end needles after use, helping reduce needlestick exposure risk to patients and healthcare professionals.
5mm length and 30G (0.30mm) thin-wall needle design support reliable subcutaneous delivery and help reduce the risk of inadvertent intramuscular injections, which may lower hypoglycaemia risk associated with IM insulin delivery.
Thin wall technology maintains very fine external needle dimensions while increasing inner diameter, improving insulin flow rate and requiring less injection force.
Compatible with all or leading brands of insulin and GLP-1 medication pens, simplifying device selection and standardisation across clinical settings.
Passive safety mechanism requires no extra activation step; safety shields automatically deploy, supporting single-handed injection technique and reducing handling of exposed needles.
Sterile, single-use, radiation-sterilised needle helps reduce risk of cross-contamination and infection when used according to instructions.
Latex-free construction reduces the risk of latex-associated hypersensitivity reactions.
Designed and tested to meet relevant international standards for needle-based injection systems and sharps injury protection, supporting consistent performance, fit, and dose accuracy.

Indications

Use with compatible pen injector devices for the subcutaneous injection of drugs (for example, insulin and other diabetes medications) in adults and children, as directed by a healthcare professional.
Intended for single-use injections performed either by healthcare professionals in clinical environments or by patients/caregivers in home or community settings.
Use where a safety-engineered pen needle with front- and back-end automatic needle shielding is desired to reduce the risk of needlestick injuries and bloodborne pathogen exposure.

Composition

Cannula: Stainless steel 304 with lubricant.
Non-patient-end spring: Stainless steel type 302.
Patient-end spring: Stainless steel type 302.
Hub: Polypropylene.
Non-patient shield (pen-end shield): Polycarbonate with orange colorant.
Inner shield: Polycarbonate with printed visual indicator band.
Outer shield: Clear polycarbonate.
Sleeve: Polycarbonate with printed BD logo.
Cover: Polyethylene.
Unit label and sterility barrier: Paper / copolymer foil.
Between inner shield and hub: Silicone grease.
Adhesive: UV-cured adhesive.
Sterilisation: Radiation (gamma).
Latex-free: Product does not contain natural rubber latex.

Formulation

Needle gauge: 30G (0.30mm outside diameter).
Needle length: 5mm.
Configuration: Double-ended cannula assembled into an injection-moulded hub with internal threads for attachment to pen injector devices.
Safety mechanism: Dual automatic protective shields that lock at both patient-end and pen-end after use.
Use: Subcutaneous injections only, via compatible pen injector devices.
Sterility: Supplied sterile, single use only.
Medical device classification (EU): Class IIa (Medical Devices Directive 93/42/EEC) for BD AutoShield Duo pen needles.
Typical pack configuration: 100 sterile pen needles per box; 800 units per shipper (outer carton) for reference 329605.

Packaging

Each pen needle is individually packaged with an outer cover and peel-away label providing a sterile barrier and tamper evidence.
Box: 100 sterile, single-use BD AutoShield Duo 0.30mm (30G) x 5mm safety pen needles (reference 329605).
Shipper/carton: 8 boxes per shipper (800 pen needles) for reference 329605, as specified in the technical data sheet.
Labelling according to the European Medical Device Directive, including CE marking and relevant symbols for single use, sterility, and safety features.

Usage

Use only with compatible pen injector devices and only after receiving appropriate training in injection technique and pen needle handling.
Before use, check the packaging for damage and verify product details (gauge, length, reference, expiry date). Do not use if sterile barrier is damaged or if the product is expired.
Remove the pen cap, clean the pen rubber septum per local protocol, and pull the peel tab off the pen needle blister.
Holding the outer cover, screw the BD AutoShield Duo pen needle straight onto the pen injector device until secure, following the pen manufacturer’s instructions.
Remove the outer cover; the pen connection end of the needle is protected by its shield before use.
Prime the pen according to the pen manufacturer’s instructions for use, ensuring that the needle is correctly attached and insulin flow has been established.
Select an appropriate injection site (e.g., abdomen, thigh, upper arm, buttocks) and rotate injection sites as recommended; avoid injecting into areas of lipohypertrophy.
Place the pen needle at a 90° angle to the skin and press to inject; the front shield will retract during insertion and injection.
After the injection is completed, keep the pen steady and then withdraw the needle from the skin; the front shield automatically advances and locks over the patient-end needle.
Remove the pen needle from the pen; upon removal, the pen-end shield automatically covers and locks over the pen-end needle.
Immediately dispose of the used pen needle (with both shields locked) in an approved sharps container; do not recap, bend, or manually manipulate the exposed needle.
Do not reuse or resterilise. Follow local clinical guidelines, institutional policies, and the manufacturer’s instructions for use for complete directions, warnings, and precautions.

Contraindications

Do not use in patients with known hypersensitivity or allergy to any of the device materials (for example, stainless steel, polycarbonate, polypropylene, polyethylene, silicone lubricant, or adhesive components).
Do not use if the sterile packaging is damaged, compromised, or opened prior to use.
Do not reuse, reprocess, or resterilise; re-use may increase risk of infection, needle dullness, and device malfunction.
Not intended for intramuscular or intravenous injection; use only for subcutaneous administration as directed by a healthcare professional.
Follow all device-specific warnings and precautions provided in the manufacturer’s instructions for use and relevant clinical guidelines.

Adverse Effects

Local pain, stinging, or discomfort at the injection site.
Minor bleeding or bruising at the injection site following needle insertion or removal.
Local reactions such as erythema, swelling, or irritation at the injection site.
Potential infection at the injection site if aseptic technique is not properly followed.
Lipohypertrophy or lipoatrophy at injection sites with poor site rotation and long-term insulin therapy (medication-related effect).
Rare hypersensitivity or allergic reactions to device materials in susceptible individuals.
Needlestick injury risk to users or caregivers if the device is not used, handled, or disposed of according to instructions, although dual safety shields are designed to reduce this risk.

Storage Conditions

Store in original packaging until point of use to maintain sterility and protect from contamination.
Keep in a clean, dry environment away from excessive moisture, dirt, and direct sunlight.
Store at typical room temperature conditions and avoid extremes of heat or cold as indicated on the product labelling.
Do not use after the expiry date printed on the packaging.
Protect packaging and contents from mechanical damage, crushing, or deformation.

Duration

Single-use per injection; each pen needle is intended for one subcutaneous injection only. Ongoing treatment duration is determined by the prescribed drug regimen and clinical guidance, not by the needle itself.

Onset

Needle provides immediate access for subcutaneous drug delivery upon correct insertion; clinical onset of drug effect depends on the medication, dose, and patient-specific factors rather than on the pen needle.