BD Whitacre Pencil Point Spinal Needle 24G 3 1/2\ (0.55 mm x 90 mm) box of 25
Becton Dickinson
Injection & InfusionSpinal needle \u2013 Whitacre pencil-point 24G x 90 mm
Certifications
- CE Marked medical device (CE certification 0318).
- Class II anaesthesia conduction needle under 21 CFR 868.5150 (US FDA 510(k) cleared family including BD Whitacre Spinal Needles).
- Designed and tested in accordance with ISO 594 (luer connector performance).
- Designed and tested in accordance with ISO 7864:2016 (sterile hypodermic needles for single use – mechanical requirements, including cannula pull force).
- Biocompatibility evaluated per ISO 10993 1:2018, including tests for cytotoxicity (ISO 10993 5), sensitisation and intracutaneous reactivity (ISO 10993 10), acute systemic toxicity and pyrogenicity (ISO 10993 11), and chemical characterisation (ISO 10993 18).
- Additional testing reported for hemolysis (ISO 10993 4), endotoxin levels (USP <85>), particulate matter (USP <788>) and neurotoxicity assessment.
- Sterilised with ethylene oxide (EO) to a sterility assurance level (SAL) of 10⁻⁶.
- CE Marked medical device (CE certification 0318).
- Class II anaesthesia conduction needle under 21 CFR 868.5150 (US FDA 510(k) cleared family including BD Whitacre Spinal Needles).
- Designed and tested in accordance with ISO 594 (luer connector performance).
- Designed and tested in accordance with ISO 7864:2016 (sterile hypodermic needles for single use – mechanical requirements, including cannula pull force).
- Biocompatibility evaluated per ISO 10993 1:2018, including tests for cytotoxicity (ISO 10993 5), sensitisation and intracutaneous reactivity (ISO 10993 10), acute systemic toxicity and pyrogenicity (ISO 10993 11), and chemical characterisation (ISO 10993 18).
- Additional testing reported for hemolysis (ISO 10993 4), endotoxin levels (USP <85>), particulate matter (USP <788>) and neurotoxicity assessment.
- Sterilised with ethylene oxide (EO) to a sterility assurance level (SAL) of 10⁻⁶.
Spinal needle \u2013 Whitacre pencil-point 24G x 90 mm
Description
The BD Whitacre Pencil Point Spinal Needle 24G 3 1/2\ (0.55 mm x 90 mm, REF 405104) is a sterile, single-use Whitacre pencil-point spinal needle with a side port and low-glare, colour-coded purple hub. It is intended for access to the spinal cavity to introduce medicines (including spinal anaesthetics) or contrast agents, or to withdraw cerebrospinal fluid (CSF) for diagnostic procedures such as lumbar puncture and myelography. The needle consists of a stainless-steel cannula bonded to a clear/polypropylene hub with a matching stainless-steel stylet, supplied in primary sterile packaging and boxed in units of 25 needles.
Bnefits
- Whitacre pencil-point tip with side port designed to minimise the risk of postdural puncture headache (PDPH) compared with larger-gauge cutting needles.
- Distinct tactile "click" or "pop" as the pencil-point penetrates the dura, helping clinicians recognise correct placement.
- Clear, low-glare hub to aid visualisation of CSF and improve precision of needle placement.
- Precision-formed side hole to help directional flow of anaesthetic agents and reduce the possibility of straddling the dura.
- Available in fine 24G gauge with 90 mm length to support spinal anaesthesia and diagnostic lumbar puncture in adult and paediatric patients.
- Sterile, single-use device with 5-year shelf life, supporting infection prevention and consistent performance.
- CE-marked medical device (CE 0318) and designed and tested in line with relevant ISO and biocompatibility standards.
Indications
- To gain entry into or puncture the spinal cavity to permit injection of medicines, including local anaesthetic agents, into the intrathecal space.
- To withdraw cerebrospinal fluid (CSF) for diagnostic lumbar puncture procedures.
- To permit injection of contrast media for myelography procedures.
- Intended for use in adult and paediatric patients when a spinal needle is required for anaesthesia or diagnostic procedures, as determined by a qualified clinician.
Composition
- Cannula: stainless steel hollow needle (spinal needle cannula).
- Needle tip: Whitacre (pencil-point) spinal tip with side port.
- Needle hub: polypropylene, low-glare, colour-coded (purple for 24G).
- Stylet wire: stainless steel.
- Stylet handle: polypropylene with colourant corresponding to gauge.
- Adhesive/bonding: epoxy or insert-moulded bond between cannula and hub.
- Needle shield (where supplied): polypropylene protective shield.
- Connector: ISO 594 compliant hub design.
- Sterilisation: ethylene oxide (EO) sterilised (sterile, single use).
Formulation
- Medical device (spinal needle) – no medicinal formulation.
- Sterile, single-use, EO-sterilised spinal needle for intrathecal access.
Packaging
- Primary packaging: 1 sterile spinal needle per primary pack/blister.
- Shelf box (shelfpack): 25 needles (box of 25).
- Shipping case: 200 needles (8 shelf boxes of 25).
- Commercial sale unit on Medisave: box of 25 BD Whitacre Pencil Point Spinal Needles 24G 3 1/2" 90 mm.
Usage
- For use only by appropriately trained healthcare professionals experienced in spinal anaesthesia and lumbar puncture techniques.
- Verify integrity of sterile packaging and check product information, gauge and length (24G x 90 mm, REF 405104) before use.
- Maintain strict aseptic technique in line with local protocols and clinical guidelines when performing spinal procedures.
- Select the appropriate intervertebral space and patient position according to the intended procedure and clinical judgement.
- Introduce the spinal needle in accordance with accepted spinal anaesthesia or lumbar puncture techniques until CSF is visualised in the clear hub, confirming intrathecal placement.
- Inject medicines or contrast agents, or withdraw CSF, only after correct placement has been verified by a qualified clinician.
- After the procedure, remove the needle and immediately discard the entire device as sharps waste in an approved sharps container.
- Single use only – do not resterilise, reprocess or reuse.
Contraindications
- Device-specific contraindications are not separately listed by the manufacturer; use is governed by clinical contraindications to spinal anaesthesia or lumbar puncture (for example, as defined in local protocols and clinical guidelines).
- Use is contraindicated in situations where sterile, single-use spinal needle procedures cannot be performed according to accepted medical practice.
Adverse Effects
- The manufacturer’s documentation focuses on design features intended to minimise postdural puncture headache (PDPH) compared with larger-gauge cutting spinal needles; overall risk profile is determined by the spinal procedure itself.
- As with all spinal needle procedures, potential complications are related to spinal anaesthesia or lumbar puncture (for example PDPH, bleeding, infection or neurological complications) and should be managed according to clinical guidelines.
Storage Conditions
- Store in original unopened packaging until point of use to maintain sterility.
- Observe the stated 5-year shelf life from the date of manufacture as specified by BD.
- Store in a clean, dry environment in accordance with local medical device storage policies and the instructions for use.
Duration
Not applicable \u2013 this is a single-use spinal access device; duration of effect is determined by the medicinal product administered and the clinical procedure.
Onset
Not applicable for the device itself; onset depends on the intrathecal agent or diagnostic procedure performed using the needle.
