Class IIb or III CE Marked medical device (chest decompression needle) under applicable EU/UK medical device regulations.
Manufactured under a certified quality management system for medical devices (e.g., ISO 13485).
Radiopaque catheter containing 20% barium sulphate for compliance with imaging and safety standards.
Class IIb or III CE Marked medical device (chest decompression needle) under applicable EU/UK medical device regulations.
Manufactured under a certified quality management system for medical devices (e.g., ISO 13485).
Radiopaque catheter containing 20% barium sulphate for compliance with imaging and safety standards.
Single Use, sterile product meeting relevant sterility assurance and packaging integrity standards.
Chest Decompression / Needle Thoracostomy
Description
The Russell PneumoFix-8 is a sterile, single-use chest decompression device designed for the emergency management of tension pneumothorax, simple pneumothorax and pleural effusion by appropriately trained medical professionals. It consists of a stainless steel Veress-tipped needle housed within an 8 cm Tecoflex polyurethane catheter that contains 20% barium sulphate for X-ray visibility. A one-way low-pressure release valve allows air or fluid to escape from the pleural cavity while minimising the risk of re-entry. Graduated depth markings and an X-ray detectable catheter assist with accurate placement and localisation. The 14-gauge catheter bore permits rapid venting of air in tension pneumothorax.
Bnefits
Purpose-designed sterile decompression device for management of tension pneumothorax, simple pneumothorax and pleural effusion by trained professionals.
Veress-tipped needle and indicator mechanism assist safer chest wall penetration, helping reduce risk of lung injury during insertion.
8 cm catheter length designed to reach the pleural cavity in the majority of adult patients with chest wall thickness up to approximately 8 cm.
One-way low-pressure release valve allows controlled evacuation of air or fluid while minimising risk of air re-entry.
14-gauge catheter provides a large internal diameter for rapid venting of air in tension pneumothorax.
Tecoflex polyurethane catheter with 20% barium sulphate is radiopaque, enabling visualisation and localisation on X-ray.
Graduated depth markings on the catheter assist with accurate insertion depth recording and later confirmation in hospital.
Female luer connector on the Veress needle permits attachment of a syringe for aspiration and confirmation of pleural space entry.
Supplied sterile and single-use, reducing infection risk associated with reprocessing.
Compact, pre-assembled design supports rapid deployment in pre-hospital, emergency department and critical care environments.
Indications
Emergency decompression of suspected or confirmed tension pneumothorax in adults and suitable older adolescents, when performed by appropriately trained medical professionals.
Single Use, sterile product meeting relevant sterility assurance and packaging integrity standards.
Needle thoracostomy in cases of simple pneumothorax where decompression using this type of device is indicated according to local protocols.
Drainage of air and, where appropriate, fluid (pleural effusion) from the pleural cavity as part of emergency management algorithms when guided by current clinical guidelines and training.
Use in pre-hospital, emergency department, military and other acute care settings under established protocols.
Composition
Stainless steel Veress-tipped needle.
Tecoflex polyurethane catheter (8 cm length).
Barium sulphate (20%) incorporated into the catheter material to make it radiopaque on X-ray.
Female luer connector compatible with standard syringes.
Printed graduated depth markings on catheter surface.
Formulation
Sterile, single-use chest decompression device.
Stainless steel Veress-tipped needle inserted through an 8 cm Tecoflex polyurethane catheter containing 20% barium sulphate.
14-gauge catheter providing a large-bore lumen for rapid air venting.
Integrated one-way low-pressure release valve for controlled decompression.
Graduated markings and X-ray detectable catheter for depth recording and localisation.
Female luer connector for syringe attachment during placement and confirmation.
Packaging
Individually packaged sterile device (single Russell PneumoFix-8) in a peel-open sterile pouch.
Outer labelling typically includes product name, product code (PDF109 or regional equivalent), lot number and expiry date.
Pack dimensions approximately 22.5 cm x 4.6 cm as per datasheet.
Supplied as single units or boxed quantities depending on distributor (e.g., boxes of multiple individual sterile devices).
Usage
For use only by appropriately trained medical professionals familiar with current guidelines for diagnosis and management of tension pneumothorax and needle thoracostomy.
Confirm clinical suspicion of tension pneumothorax or other indication according to local protocols before using the device.
Inspect packaging to ensure sterility and integrity; do not use if the sterile pouch is damaged or if the device appears compromised.
Select the appropriate insertion site according to current clinical guidelines and training (e.g., 2nd intercostal space mid-clavicular line or 4th/5th intercostal space anterior axillary line, depending on protocol).
Prepare the skin using aseptic technique and position the patient as per local practice and clinical condition.
Attach a syringe to the female luer connector if required by local technique to confirm pleural entry; insert the Veress-tipped needle and catheter perpendicular or as otherwise indicated to the chest wall, advancing until pleural space entry is indicated (e.g., change in resistance or aspirated air/fluid).
Advance the catheter over the needle into the pleural space and withdraw the needle according to the Instructions for Use, ensuring the one-way valve is correctly orientated for decompression.
Monitor the patient continuously and reassess clinical status; secure the catheter according to local practice to minimise accidental dislodgement.
Arrange definitive care, imaging and chest drainage where appropriate, as the device is intended as an emergency decompression measure and not as a long-term chest drain.
Dispose of the used needle and catheter as sharp clinical waste in accordance with local regulations; do not reuse.
Contraindications
Patients without clinical or investigational evidence of tension pneumothorax, simple pneumothorax or pleural effusion where decompression is indicated.
Patients known to have pleural adhesions (visceral and parietal pleura adherent), which may increase risk of organ injury.
Patients known or suspected to have a chest wall thickness greater than approximately 8 cm at the intended insertion site (may result in failure to reach pleural cavity).
Use in anatomical locations or patient groups not covered by local training or protocols.
Use by personnel who are not appropriately trained or authorised to perform chest decompression procedures.
Relative contraindications where alternative management is more appropriate as per current clinical guidelines and expert judgement.
Adverse Effects
Potential for failure to decompress if catheter does not reach the pleural space or becomes kinked or occluded.
Risk of injury to underlying structures, including lung, intercostal vessels, heart, great vessels or abdominal organs, particularly if inserted incorrectly.
Bleeding or haematoma at the insertion site.
Infection at the insertion site or within the pleural space if aseptic technique is not maintained.
Subcutaneous emphysema if air tracks into subcutaneous tissues rather than freely venting from the pleural cavity.
Re-expansion pulmonary oedema as a rare complication of rapid decompression in some patients.
Pain or discomfort at the insertion site, which may require appropriate analgesia.
Catheter dislodgement or malfunction, necessitating reassessment and potential re-intervention.
Storage Conditions
Store in a clean, dry environment at room temperature within the range specified on the packaging (typically standard medical device storage conditions).
Keep away from direct sunlight, excessive heat and moisture.
Do not use if the product has been stored outside the recommended conditions, or if packaging is damaged or opened.
Do not re-sterilise; device is supplied sterile and intended for single use only.
Keep out of the reach of children and unauthorised personnel.
Duration
Single-use emergency device intended for immediate decompression and short-term use until more definitive management (e.g., chest tube insertion) is established or the device is removed according to clinical judgement.
Onset
When correctly placed in an appropriate case of tension pneumothorax, decompression and clinical improvement are expected to occur rapidly (within minutes) as air is vented from the pleural space through the catheter and low-pressure release valve; continuous monitoring is essential.
