Perican 16 18G x 80mm NRFit EU Epidural Needle (Carton of 25)

B. Braun

Injection & Infusion

Epidural needle with Tuohy bevel (regional anaesthesia, NRFit connector)

Conforms to ISO 80369 6 for neuraxial (NRFit) small Bore connectors.
CE Marked medical device (Class III) under applicable European medical device regulations.
Subject to B. Braun quality management system and relevant standards for sterile single Use invasive devices.

Conforms to ISO 80369 6 for neuraxial (NRFit) small Bore connectors.
CE Marked medical device (Class III) under applicable European medical device regulations.
Subject to B. Braun quality management system and relevant standards for sterile single Use invasive devices.

Epidural needle with Tuohy bevel (regional anaesthesia, NRFit connector)

Description

Perican 18G x 80mm NRFit-EU is a single-use epidural needle from B. Braun designed for regional anaesthesia procedures. It features a Tuohy-type bevel for epidural access and an NRFit connector in accordance with ISO 80369-6 to help reduce the risk of misconnections with non-neuraxial systems. The needle has 1 cm graduations along its 80 mm shaft for depth control, small wings for stable handling, a translucent hub for visual confirmation of cerebrospinal fluid or blood reflux, and a colour-coded stylet hub indicating gauge size. This 18G x 80 mm NRFit variant is suitable for both single-shot epidural techniques and for use with an epidural catheter, and is supplied as a sterile carton of 25 needles for hospital use.

Bnefits

NRFit connector compliant with ISO 80369-6 for neuraxial and regional anaesthesia, designed to minimise wrong-route misconnections with IV and other non-neuraxial systems.
Tuohy-type bevel optimised for epidural access and for use with compatible epidural catheters.
1 cm shaft graduations support accurate measurement of insertion depth and needle positioning.
Integrated wings provide improved grip and control during needle advancement and positioning.
Translucent needle hub allows visual detection of CSF or blood reflux for confirmation of needle placement.
Colour-coded stylet hub clearly indicates the 18G needle size for quick identification.
Available as NRFit-EU configuration specifically for regional/neuraxial use in line with current safety standards.
Suitable for both continuous and single-shot epidural techniques, providing flexibility in clinical practice.
Supplied sterile and ready to use, helping support infection prevention in the clinical setting.

Indications

Epidural anaesthesia and analgesia in adults and appropriate patient groups, as determined by clinical judgement.
Regional neuraxial procedures requiring an epidural Tuohy needle for placement of an epidural catheter.
Single-shot epidural techniques where an epidural needle is used without catheter placement.
Use in operating theatres, obstetrics, pain management and other settings where epidural anaesthesia is indicated.

Composition

Epidural needle manufactured primarily from medical-grade stainless steel.
Tuohy-type bevel tip designed for controlled entry into the epidural space.
Translucent plastic needle hub for visualisation of fluid reflux.
Colour-coded stylet hub indicating 18G size (pink hub in typical Perican 18G configuration).
Integrated plastic wings attached to the hub to assist needle stabilisation and handling.
NRFit small-bore connector geometry designed for neuraxial/regional applications in line with ISO 80369-6.

Formulation

Single-use, sterile epidural needle with Tuohy bevel.
Size: 18G (outer diameter approximately 1.30 mm) x 80 mm length.
NRFit-EU connector for neuraxial/regional anaesthesia systems.
1 cm graduations along the shaft for depth marking.
Supplied with a matching stylet and colour-coded stylet hub.

Packaging

Carton containing 25 individually packed Perican 18G x 80mm NRFit-EU epidural needles.
Each needle supplied sterile in a peel-open blister or pouch for single use.
Outer carton labelled with product name, size, NRFit configuration, batch/lot number, expiry date and regulatory symbols.
Packaging designed for hospital storage and easy identification on shelves or within anaesthesia trolleys.

Usage

Use only by clinicians trained and experienced in epidural and regional anaesthesia techniques, and familiar with neuraxial safety standards.
Verify the product label (Perican 18G x 80mm NRFit-EU), integrity of the sterile packaging, expiry date and gauge/length before opening.
Prepare the patient and the epidural site according to institutional protocols, including appropriate monitoring, aseptic skin preparation and draping.
Open the sterile pack and maintain aseptic technique when handling the needle, stylet and associated equipment.
Attach the needle to compatible NRFit syringes or devices as required; do not attempt to connect to non-NRFit connectors.
Advance the needle with the stylet in place using standard epidural technique, using the 1 cm graduations to monitor insertion depth and wings to stabilise the needle.
Use appropriate technique (e.g. loss-of-resistance) to identify the epidural space; observe the translucent hub and stylet for CSF or blood reflux as clinically indicated.
If placing an epidural catheter, withdraw the stylet and advance the catheter through the needle into the epidural space according to protocol, then withdraw the needle while securing the catheter.
Dispose of the used needle immediately after use in a suitable sharps container; do not reuse or resterilise.
Follow all locally approved guidelines and manufacturer’s instructions for use, including compatibility with other components of the epidural/NRFit system.

Contraindications

Do not use in patients with contraindications to epidural or neuraxial anaesthesia, such as uncorrected coagulopathy, infection at the puncture site, or raised intracranial pressure, unless specifically assessed and approved by an anaesthetist.
Do not use if sterile barrier has been compromised, the packaging is damaged, or the expiry date has passed.
Do not use in patients with known hypersensitivity to any component of the epidural system where this may be clinically relevant.
Do not use with non-NRFit connectors or attempt to modify the connector, as this may compromise safety and performance.
Do not reuse or resterilise; product is designed and validated for single use only.

Adverse Effects

As with any epidural procedure, potential complications include inadvertent dural puncture, post-dural puncture headache, epidural haematoma, infection (such as epidural abscess), nerve injury or inadequate block.
Local site complications may include bleeding, bruising or local infection at the puncture site.
Potential for vascular puncture or intravascular injection if appropriate technique and aspiration checks are not followed.
Pain or discomfort during needle insertion, particularly if local anaesthesia of the skin is inadequate.
Device-related issues such as needle blockage or difficulty advancing may occur; in such cases the needle should be discarded and replaced rather than forced.

Storage Conditions

Store in a clean, dry environment at room temperature within the range specified on the packaging.
Protect from excessive heat, moisture and direct sunlight.
Keep in original packaging until point of use to maintain sterility and protect from physical damage.
Do not use if packaging is wet, torn, punctured or otherwise compromised.
Keep out of reach of unauthorised persons and children; for professional use only.

Duration

The needle itself is used for a single insertion during epidural or regional anaesthesia procedures. Duration of anaesthesia or analgesia is determined by the local anaesthetic regimen and any indwelling epidural catheter rather than by the needle.

Onset

Onset of clinical effect depends on the local anaesthetic or analgesic agent administered via the epidural route and patient factors; the needle serves solely as an access device and does not determine onset time.