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BD™ Blunt Fill Needle 18 G x 1 in. special packaging

BD™ Blunt Fill Needle 18 G x 1 in. special packaging

Becton Dickinson

Medical device – blunt fill needle for medication preparation
  • CE Marked medical device under the Medical Devices Directive 93/42/EEC for product codes including 305181, with CE certification issued by NSAI (Notified Body 0050), certificate number 252.308.
  • Manufacturer quality management system certified to ISO 13485 (ISO 13485 certificate MD19.2305 for Becton, Dickinson and Company; additional ISO 13485 certification for the BD Medical Surgical manufacturing site in Columbus, NE, USA).
  • Compliance with EN 556 1 requirements for terminally sterilised medical devices designated as ‘STERILE’.
  • Biocompatibility evaluated according to ISO 10993 series for biological evaluation of medical devices.
  • Sterilisation validated according to EN ISO 11137 for radiation sterilisation of healthcare products.
  • Packaging system validated according to EN ISO 11607 1 and EN ISO 11607 2 for terminally sterilised medical devices.
  • Luer connection design in accordance with EN 20594 1 / ISO standards for 6% conical fittings (Luer) for syringes and needles.
  • Manufactured under an ISO 13485 Certified quality management system with risk management processes aligned to EN ISO 14971.
  • Product and packaging not intentionally manufactured with PVC, phthalates (including DEHP) or natural rubber latex; REACH compliance programme in place with no listed SVHC above 0.1% w/w for referenced product numbers as of the cited technical data sheet date.
Blunt fill needle, 18 G x 1 in, thin wall, medication preparation only

Description

The BD™ Blunt Fill Needle 18 G x 1 in. (REF 305181) is a sterile, single-use, latex-free, blunt-tip needle with a thin wall (TW) design and red Luer hub, intended for aspiration and transfer of fluids from vials and ampoules during medication preparation. It is specifically designed to help reduce the risk of needlestick injuries by using a blunt bevel that requires substantially greater force than a conventional sharp needle to penetrate skin, while still easily penetrating vial stoppers and minimizing coring. The needle is not intended for injection into patients.

Bnefits

  • Helps reduce the risk of needlestick injuries during medication preparation by using a blunt bevel that requires much higher force to penetrate skin compared with conventional sharp hypodermic needles.
  • Designed to be used only for aspiration and transfer of medications from vials and ampoules, eliminating unnecessary use of sharp needles for preparation tasks.
  • Thin wall (TW) 18 G design provides a larger inner diameter than a regular wall needle of the same gauge, which may improve flow rates for viscous medications during draw-up.
  • Reduces the need for a broad selection of conventional draw-up needles, supporting SKU standardisation, inventory simplification and potential cost efficiencies.
  • Blunt design helps reduce coring when piercing vial stoppers, contributing to cleaner medication preparation.
  • Sterile, single-use device with radiation sterilisation and validated shelf life supports infection prevention when used according to instructions.
  • Latex-free, DEHP-free, BPA-free (above 0.1% w/w) and PVC-free design reduces exposure to materials of concern for sensitive patients and staff.
  • Complies with relevant international standards for biocompatibility, sterilisation and luer fittings, supporting consistent, reliable performance.

Indications

  • Aspiration and transfer of fluids or medications from vials and ampoules into a syringe during medication preparation.
  • Use in hospital, clinic, outpatient and pharmacy environments by trained healthcare professionals for medication draw-up.
  • Situations where a blunt needle is preferred over a conventional sharp needle to reduce risk of needlestick injury during medication preparation.
  • Not indicated for skin injections; the needle is not intended to be used for intradermal, subcutaneous, intramuscular or intravenous injection into patients.

Composition

  • Needle/cannula: Stainless steel (type 304) with medical-grade silicone lubricant on the cannula.
  • Needle hub (fill needles including 305181): Polypropylene with colourant (red for 18 G).
  • Needle shield: Polypropylene with colourant.
  • Adhesive/bonding agent: Epoxy adhesive (may contain very low levels of Bisphenol A in the adhesive, below 0.1% w/w).
  • Lubricant: Medical-grade silicone oil on the cannula.
  • Filter: Not applicable for 305181 (no filter membrane; filter needle 305211 only).
  • Packaging materials: Paperboard carton, paper/film sterile barrier materials.
  • Materials of concern: Product and packaging are not intentionally manufactured with phthalates (including DEHP), natural rubber latex or PVC; any Bisphenol A present is at very low residual levels in adhesive and below regulatory thresholds.

Formulation

  • Needle gauge: 18 G.
  • Needle length: 1 in. (25 mm).
  • Tip type: Blunt bevel, not designed for skin penetration.
  • Needle wall type: Thin wall (TW) design for improved internal flow compared to regular wall.
  • Hub colour: Red (standard colour coding for 18 G).
  • Hub type: Standard Luer hub compatible with Luer and Luer-Lok™ syringes (6% Luer taper in accordance with EN 20594-1 / ISO standards).
  • Intended use: Medication preparation (aspiration from vials and ampoules), not for injection.
  • Sterilisation method: Radiation sterilisation validated according to EN ISO 11137 for healthcare products.
  • Shelf life: 5 years from date of manufacture under recommended storage conditions.
  • Latex status: Not formulated with natural rubber latex.
  • Phthalates and PVC: Not intentionally manufactured with DEHP/phthalates or PVC.

Packaging

  • Each blunt fill needle is individually packaged in a sterile blister or peel-open unit pack, labelled with product identification, gauge, length and lot/expiry information.
  • Shelfpack (box): 100 sterile, single-use BD™ Blunt Fill Needles 18 G x 1 in. (special packaging configuration).
  • Case: 1,000 needles per case (10 boxes of 100), as per BD GTIN case quantity for REF 305181.
  • GTIN – Each: 00382903051816 (1 unit).
  • GTIN – Shelfpack (box of 100): 30382903051817.
  • GTIN – Case (1,000 units): 50382903051811.
  • Box dimensions (approximate): height 9.8 cm, length 11.6 cm, width 8.8 cm.
  • Case dimensions (approximate): height 12.95 cm, length 44.7 cm, width 18.03 cm.

Usage

  • Use only by trained healthcare professionals familiar with safe medication preparation practices and institutional policies.
  • Inspect the unit package before use; do not use if the sterile barrier is damaged, opened or if the product is past its expiry date.
  • Open the sterile package and attach the BD™ Blunt Fill Needle firmly to a compatible Luer or Luer-Lok™ syringe, following standard aseptic technique.
  • For vials, remove the vial cap if present, disinfect the rubber stopper with an appropriate antiseptic and allow it to dry according to institutional protocol.
  • Insert the blunt fill needle through the vial stopper using steady pressure; the design allows penetration of vial stoppers while minimizing coring.
  • Invert the vial as appropriate and withdraw the required volume of medication into the syringe, ensuring no air bubbles as per local guidelines.
  • For ampoules, open the ampoule safely according to protocol, then insert the blunt fill needle into the ampoule to aspirate the medication.
  • After drawing up the medication, remove the blunt fill needle from the vial or ampoule and detach it from the syringe, taking care to avoid contact with the needle tip.
  • Discard the used blunt fill needle immediately into an approved sharps container; do not attempt to recap, bend or reuse the needle.
  • Attach an appropriate administration needle, safety needle or infusion device for patient injection as per local policy and the drug prescriber’s instructions.
  • Always follow the manufacturer’s instructions for use, institutional protocols, and applicable standards for sharps safety and aseptic technique.

Contraindications

  • Not for injection into patients: do not use the blunt fill needle for intradermal, subcutaneous, intramuscular or intravenous administration.
  • Do not use in any situation requiring penetration of skin or tissue; use only for drawing up fluids from vials and ampoules.
  • Do not use if the sterile packaging is damaged, opened, or shows signs of contamination.
  • Do not reuse, reprocess or resterilise; single-use device only.
  • Do not use in individuals with known hypersensitivity or allergy to stainless steel, polypropylene, silicone oil, epoxy adhesive or other device components.
  • Do not use with non-Luer compatible devices or where a standard Luer connection is not appropriate or safe.
  • Follow any additional contraindications, warnings and precautions specified in the manufacturer’s instructions for use and local clinical guidelines.

Adverse Effects

  • If misused for injection into patients (contrary to intended use), potential tissue trauma, pain or bleeding could occur due to the blunt bevel.
  • Risk of needlestick injury to staff remains if the needle is handled improperly or disposed of incorrectly, although the blunt design is intended to reduce this risk compared with sharp needles.
  • Risk of contamination of medications or equipment if aseptic technique is not followed during medication preparation.
  • Very rare risk of hypersensitivity or allergic reactions in users with sensitivity to device materials such as stainless steel, silicone or epoxy components.
  • Potential coring of vial stoppers is minimised but may still occur if technique or stopper condition is suboptimal.

Storage Conditions

  • Store in the original packaging until use to maintain sterility and protect from contamination.
  • No special storage conditions are required beyond normal dry, indoor storage; keep in a clean, dry environment and avoid excessive humidity.
  • Store in a dry and reasonably warm place, protected from strong or direct light, as indicated in the technical data sheet.
  • Avoid extreme temperatures and environmental conditions that could compromise packaging integrity.
  • Observe the labelled shelf life (typically 5 years); do not use after the expiry date printed on the packaging.
  • Protect from mechanical damage, crushing, or deformation of individual packs and cartons.

Duration

Not applicable \u2013 the device is a single-use draw-up needle used transiently during medication preparation; each needle is intended for one medication preparation episode only and is not left in situ.

Onset

Not applicable to the needle itself; it is used solely for medication preparation. Clinical onset of effect depends on the medication prepared and the route of administration, not on the blunt fill needle.

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