BD Whitacre Pencil Point Spinal Needle 22 27G

Becton Dickinson

Medical device

Spinal needle (Whitacre pencil point)

CE Marked medical device under EU medical device regulations (Whitacre spinal needle family, including size 27G x 119 mm).
FDA 510(k) Cleared in the United States as an anaesthesia conduction needle under 21 CFR 868.5150 (Whitacre spinal needle family).
Class II device in the United States; treated as high Risk class (e.g. Class III) in some EU regulatory documentation.
Manufactured under an ISO 13485:2016 Certified quality management system.
Conforms to international standards for sterile, single Use hypodermic and spinal needles, including colour coding of hubs per ISO 6009.

CE Marked medical device under EU medical device regulations (Whitacre spinal needle family, including size 27G x 119 mm).
FDA 510(k) Cleared in the United States as an anaesthesia conduction needle under 21 CFR 868.5150 (Whitacre spinal needle family).
Class II device in the United States; treated as high Risk class (e.g. Class III) in some EU regulatory documentation.
Manufactured under an ISO 13485:2016 Certified quality management system.
Conforms to international standards for sterile, single Use hypodermic and spinal needles, including colour coding of hubs per ISO 6009.

Spinal needle (Whitacre pencil point)

Description

The BD Whitacre Pencil Point Spinal Needle 27G 4 11/16\ (119 mm) is a long-length, high-flow, pencil-point spinal needle designed for spinal anaesthesia and diagnostic lumbar puncture. It features an atraumatic Whitacre tip with a precision-formed side hole near the tip, a grey, transparent, low-glare polypropylene hub that facilitates rapid cerebrospinal fluid (CSF) visualisation, and a thin-wall 27G stainless steel cannula intended to maximise flow while minimising dural trauma. The needle is supplied sterile for single use and is latex-free and DEHP-free.

Bnefits

Pencil-point Whitacre tip designed to spread dural fibres rather than cut them, helping to reduce the incidence of post-dural puncture headache (PDPH).
High-flow thin-wall 27G cannula to improve CSF flow rate and speed of CSF visualisation.
Distinct tactile "click" or "pop" as the pencil-point penetrates the dura, aiding confirmation of intrathecal placement.
Precision-formed side hole near the needle tip enables directional delivery of anaesthetic and reduces the risk of straddling the dura.
Transparent, colour-coded (grey) polypropylene hub with low-glare properties to enhance visualisation of CSF reflux.
Increased tip strength designed to minimise bending or breakage during advancement through ligaments.
Tracks straight through tissue, supporting more controlled and precise needle placement.
Sterile, single-use, latex-free and DEHP-free construction to support patient and clinician safety.

Indications

Gaining entry into or puncturing the spinal (subarachnoid) cavity to allow injection of intrathecal anaesthetic agents for spinal anaesthesia.
Diagnostic lumbar puncture for collection of cerebrospinal fluid (CSF).
Intrathecal injection or withdrawal of fluids in procedures such as myelography, when performed according to local clinical protocols.
Use in adult and paediatric patients when spinal needle access to the subarachnoid space is indicated and clinically appropriate.

Composition

Stainless steel needle cannula (27G thin-wall, high-flow design).
Stainless steel stylet wire.
Polypropylene needle hub (colour coded grey for 27G) with low-glare finish.
Polypropylene protective needle shield.
Epoxy adhesive used for bonding components, where not insert-moulded.
Materials are latex-free, PVC-free, DEHP-free and non-pyrogenic.

Formulation

Gauge: 27G (0.40 mm), thin-wall, high-flow spinal needle.
Length: 4 11/16 in (119 mm) long length configuration.
Tip: Whitacre pencil-point atraumatic tip with precision side hole near needle tip.
Hub: Transparent, low-glare polypropylene luer hub, colour-coded grey per ISO 6009.
Use: Sterile, single-use spinal needle supplied with stylet.
Sterilisation: Ethylene oxide (EtO) sterilised, validated to medical-device sterility standards.

Packaging

Box of 25 sterile spinal needles (Medisave UK configuration) with individual sterile packs.
Each needle supplied individually packaged in a sterile peel-open/blister pouch for single use.
Outer packaging labelled with gauge, length, lot number and expiry date.
Intended to be disposed of as clinical sharps waste after single use.

Usage

For use only by trained and qualified clinicians experienced in spinal anaesthesia and lumbar puncture.
Before use, inspect the sterile package; do not use if the package is opened, damaged or past its expiry date.
Maintain strict aseptic technique. Prepare the patient, skin and field according to institutional protocols.
Attach the spinal needle securely to a compatible syringe as required, ensuring the stylet is fully seated in the cannula.
Advance the needle slowly towards the subarachnoid space following anatomical landmarks and local guidelines, periodically checking for CSF reflux in the transparent hub.
Once free-flowing CSF is confirmed, orient the side hole as desired for directional drug delivery, remove the stylet if required, and inject or withdraw fluid according to the intended procedure.
After the procedure, withdraw the needle carefully, immediately engage appropriate sharps safety protocol and dispose of the needle in an approved sharps container.
Do not resterilise or reuse. Single use only.

Contraindications

Not publicly listed

Adverse Effects

Not publicly listed

Storage Conditions

Store in original unopened packaging in a clean, dry environment.
Keep at normal room temperature; avoid extremes of heat, moisture and direct sunlight.
Do not use if the sterile barrier pouch or outer packaging is damaged or opened.
Follow local regulations for stock rotation and expiry-date control.
Single-use sterile product; do not resterilise or reuse.