Sterile, single Use Class II medical device (port access needle) manufactured under quality systems compliant with applicable regulatory standards (e.g., ISO 13485).
Not made with natural rubber latex.
Integrated non DEHP plasticised extension tubing.
Sterile, single Use Class II medical device (port access needle) manufactured under quality systems compliant with applicable regulatory standards (e.g., ISO 13485).
Not made with natural rubber latex.
Integrated non DEHP plasticised extension tubing.
Non-coring port access (Huber) needle
Description
The GRIPPER Needle without Y-site - 19mm, 22G is a non-coring Huber-style port access needle designed for use with implantable venous access devices (ports). It features a cushioned needle platform for patient comfort and stabilization, a removable contoured grip for controlled needle placement and a lower profile after access, and a fully threaded female luer-lock connector to help minimise leakage and disconnection. The needle is manufactured from non-siliconized, medical-grade stainless steel and is supplied with an integrated non-DEHP plasticised extension tube and colour-coded clamp for gauge identification. The device is not made with natural rubber latex and is supplied sterile in boxes of 12 needles.
Bnefits
Non-coring Huber needle design helps protect the integrity of the port septum and reduces coring.
Cushioned needle platform increases patient comfort, stabilises the needle and protects the access site.
Removable contoured grip allows controlled, confident needle placement and a lower profile once removed.
Fully threaded female luer-lock connector helps minimise leakage and accidental disconnection during infusions.
Integrated non-DEHP plasticised extension tubing supports compatibility with a range of infusion setups.
Natural rubber latex-free construction reduces the risk of latex-related allergic reactions.
Colour-coded clamp provides quick visual identification of needle gauge (22G).
Pack of 12 sterile needles supports routine port access in oncology and infusion services.
Indications
Vascular access via implanted venous access ports (implantable port systems) for infusion of medications, fluids and nutritional solutions.
Intermittent or continuous administration of chemotherapy, antibiotics, parenteral nutrition and other IV therapies through an implanted port.
Sampling of venous blood through compatible implantable port systems using a non-coring Huber needle.
Use in hospital, outpatient oncology, infusion centres and home infusion settings where implanted ports are accessed.
Threaded female luer-lock connector at the distal end of the extension tubing.
Colour-coded clamp on the extension line for gauge identification and flow control.
Latex statement: natural rubber latex-free (not made with natural rubber latex).
Formulation
Device type: non-coring Huber port access needle without Y-site.
Gauge and length: 22G x 19 mm (3/4").
Configuration: straight Huber needle on cushioned platform with extension tubing and threaded female luer-lock; no Y-site.
Sterility: sterile, single-use medical device.
Packaging unit: box of 12 needles.
Packaging
Box of 12 individually sterile-packaged GRIPPER needles without Y-site (22G x 19mm).
Each needle supplied on a cushioned platform with removable contoured grip and integrated extension set.
Outer carton labelled with product name, brand (GRIPPER), manufacturer (ICU Medical), and SKU 21-2733-24.
Intended for professional healthcare use.
Usage
For use only by trained healthcare professionals familiar with implantable port access techniques and institutional protocols.
Verify package integrity and expiry date before use; do not use if the sterile pack is damaged or expired.
Prepare the patient and port access site according to aseptic technique and local policy (e.g., hand hygiene, skin antisepsis).
Prime the extension tubing and luer-lock connector with compatible solution as per protocol, ensuring all air is removed.
Align the Huber needle tip over the centre of the port septum and, using the contoured grip, advance the needle perpendicular to the skin until the needle contacts and fully penetrates the septum into the port reservoir.
Confirm correct placement by aspiration of blood and/or flush according to institutional guidelines.
After confirming patency, remove the contoured grip if desired to achieve a lower profile while leaving the needle platform in place against the skin.
Secure the needle and tubing according to protocol (e.g., transparent dressing, stabilization device) and connect the threaded female luer-lock to the infusion line or syringe.
During use, monitor the site regularly for signs of infiltration, infection or dislodgement.
At completion of therapy, stop the infusion, clamp the line, disconnect the luer-lock, remove dressing and withdraw the needle straight out from the port while following sharps safety procedures.
Dispose of the entire needle and extension set immediately in an approved sharps container; do not reuse or re-sterilise.
Contraindications
Do not use in patients with known hypersensitivity to any material in the device if clinically relevant.
Do not use if the port or surrounding skin shows signs of infection, inflammation, or other contraindications to port access unless specifically directed by a physician.
Do not use if the sterile package is open, damaged, or past the labelled expiry date.
Not intended for general intramuscular or subcutaneous injection; use only for accessing compatible implanted port systems.
Do not reuse or re-sterilise; single use only.
Adverse Effects
Local complications at the port site such as pain, bruising, bleeding, haematoma or discomfort during and after insertion.
Potential for infiltration or extravasation if the needle is not correctly seated in the port reservoir.
Risk of infection, including local site infection or systemic bloodstream infection, particularly if aseptic technique is not strictly followed.
Risk of catheter or port damage if a non-coring technique is not maintained or if inappropriate manipulation occurs.
Allergic or sensitivity reactions to device materials in susceptible individuals.
Thrombosis or occlusion of the port or catheter related to underlying vascular access and not specific to the needle design.
Storage Conditions
Store in a clean, dry environment at room temperature, away from excessive heat and direct sunlight.
Keep in original packaging until point of use to maintain sterility.
Protect from moisture and mechanical damage.
Do not use after the expiry date printed on the packaging.
Keep out of reach of unauthorised persons and children.
Duration
Single-use device intended to remain in situ only for the duration of a port access episode, in accordance with clinical judgement and institutional policy. Once removed, the needle must be discarded and not reinserted.
Onset
Not applicable; this is a vascular access device enabling infusion and blood sampling, and has no pharmacological onset of effect.
