CE Marked medical device (e.g. risk class IIa under EU medical device regulations) for intraosseous access.
FDA Cleared device for intraosseous access as an alternative to IV access during emergencies (adult and paediatric models cleared via 510(k) pathways).
Manufactured under Good Manufacturing Practice (GMP) and relevant ISO quality management systems for medical devices (e.g. ISO 13485) as required for CE and FDA regulatory compliance.
CE Marked medical device (e.g. risk class IIa under EU medical device regulations) for intraosseous access.
FDA Cleared device for intraosseous access as an alternative to IV access during emergencies (adult and paediatric models cleared via 510(k) pathways).
Manufactured under Good Manufacturing Practice (GMP) and relevant ISO quality management systems for medical devices (e.g. ISO 13485) as required for CE and FDA regulatory compliance.
Subject to local medical device regulations and vigilance reporting requirements in markets where it is distributed and used.
Description
The Bone Injection Gun (B.I.G) 15g Adult Version is a disposable, automatic, spring-loaded intraosseous (IO) device designed to provide rapid, reliable vascular access in emergency situations when conventional intravenous (IV) access is difficult or impossible. Using a simple \position and press\ deployment mechanism, the B.I.G. delivers a 15-gauge IO needle into the bone marrow cavity of the proximal tibia or proximal humerus in adult and adolescent casualties (typically aged 12 years and over). The device is preassembled, pocket-sized and requires no external power source or maintenance, enabling trained healthcare professionals and first responders to establish IO access within seconds for infusion of fluids, medications and blood products at flow rates comparable to peripheral IV infusion.
Bnefits
Provides rapid intraosseous access in less than 60 seconds when IV access is difficult or unsuccessful.
Automatic spring-loaded, single-use design with a simple "position and press" mechanism that minimises deployment time and training burden.
15G trocar needle with preset penetration depth (2.5 cm / 1 inch) optimised for adult proximal tibia and proximal humerus access.
Designed for use in extreme and high-pressure environments, including pre-hospital care, EMS, search and rescue, military battlefields and hospital emergency departments.
Pocket-sized (approximately 6.5 x 3 inches / 16.5 x 7.6 cm) and lightweight (less than 3 oz), making it easy to carry in responder bags or uniform pockets.
Ready-to-use, sterile and maintenance-free with a 5-year shelf life, supporting stocked emergency kits and mass-casualty preparedness.
Extra-safe design with no direct contact between the operator and the patient’s blood and integrated safety features (safety latch, safety wings, directional markings) to reduce user error and needlestick risk.
Compatible with standard Luer-lock infusion sets and syringes, enabling immediate delivery of crystalloid fluids, medications and blood products.
FDA-cleared and CE-marked medical device, used widely across multiple healthcare systems worldwide.
Indications
Establishing emergency intraosseous access to the vascular system when conventional IV access is difficult, delayed or impossible.
Use as an alternative to IV access during resuscitation in cardiac arrest, shock, severe trauma, burns, sepsis, status epilepticus and other life-threatening emergencies requiring rapid vascular access.
Intraosseous infusion of fluids, medications and blood products at flow rates similar to peripheral IV infusion.
IO access via the proximal tibia in adults and adolescents (typically 12 years and older) when anatomical landmarks are intact and no contraindications exist at the insertion site.
IO access via the proximal humerus (humeral head) in adults when rapid fluid or pharmacologic resuscitation is required and IV access cannot be obtained.
Intended for use by suitably trained healthcare professionals and trained first responders only.
Cannula length approximately 43.4 mm with preset penetration depth of 2.5 cm (1 inch) for adult use.
Barrel with directional safety marks to assist correct orientation at the insertion site.
Safety "wings" to aid stable handling and control during positioning and deployment.
Integrated safety latch / trigger lock to prevent accidental activation before the device is correctly positioned.
Formulation
Medical device: single-use, spring-loaded intraosseous injection gun with integrated 15G IO needle.
Preassembled, self-contained unit requiring no external power source or accessory components for deployment.
Automatic trigger mechanism that releases a spring to drive the trocar needle to a pre-determined penetration depth into the bone marrow cavity.
Designed for use on adult and adolescent patients (around 12 years and older) at the proximal tibia and, in adults, at the proximal humerus.
Packaging
Supplied as a sterile, single-use device in a compact, easy-to-open package for rapid access in emergencies.
Pocket-sized device dimensions approximately 6.5 x 3 inches (16.5 x 7.6 cm).
Lightweight construction (typically less than 3 oz) suitable for carriage in responder kits and personal gear.
Labelled with device identification (e.g. WMBIG-A1 or equivalent), gauge, needle length, lot number and expiry date.
Shelf life of up to 5 years under recommended storage conditions when packaging remains intact and unopened.
Usage
This device is intended only for use by suitably trained healthcare professionals or trained first responders familiar with intraosseous access techniques.
Select the appropriate insertion site: proximal tibia or proximal humerus in adult patients, ensuring no local contraindications (e.g. fracture, infection, previous IO attempt at that site).
Prepare the insertion site using standard aseptic skin preparation techniques in line with local protocols.
Set the device as required (e.g. confirm depth preset for adult use) and remove any safety caps according to the device instructions for use.
Position the B.I.G. at 90 degrees to the skin over the chosen landmark, aligning the directional safety marks correctly and stabilising the limb.
Release the safety latch and deploy the device using the "position and press" trigger mechanism to insert the IO needle into the bone marrow cavity.
Confirm correct IO placement according to local protocols (e.g. needle stability, ability to aspirate marrow or blood, easy infusion without significant soft-tissue swelling).
Secure the IO needle and connect standard Luer-lock infusion tubing or syringes for administration of fluids, medications and blood products.
Continuously monitor the insertion site and limb for signs of extravasation, swelling, increasing pain or compartment syndrome and discontinue use if complications are suspected.
Use the IO route as a temporary emergency access until definitive IV or central venous access is established; dispose of the used device and needle as clinical sharps according to local regulations.
Contraindications
Fracture, suspected fracture or significant trauma involving the bone at or above the proposed IO insertion site (e.g. ipsilateral tibial or humeral fracture).
Infection, cellulitis, burns or significant soft-tissue damage over the intended insertion site.
Previous IO attempt in the same bone at the same site during the current episode (use an alternative site if repeat IO access is required).
Known or suspected bone disease that may compromise bone integrity at the intended site (e.g. severe osteoporosis, osteogenesis imperfecta, local bone malignancy) where IO placement may be unsafe.
Inability to clearly identify anatomical landmarks for safe insertion (e.g. due to morbid obesity, massive tissue swelling or deformity).
Use in untrained personnel or for self-administration; the device is intended solely for trained professionals and trained first responders.
Relative contraindication in limbs with vascular compromise or where compartment syndrome is already suspected.
Adverse Effects
Pain at the insertion site and discomfort associated with IO needle placement, particularly in conscious patients.
Local soft-tissue extravasation of fluids or medications due to malposition or dislodgement of the IO needle, potentially leading to tissue swelling and pain.
Compartment syndrome of the affected limb as a result of significant extravasation of infusate into surrounding tissues.
Local infection at the insertion site and, rarely, osteomyelitis of the involved bone if aseptic technique is inadequate or dwell time is prolonged.
Mechanical complications such as bent or displaced needles, damage to growth plates in skeletally immature patients or, rarely, iatrogenic fracture of the bone.
Bleeding or haematoma formation at the puncture site.
Potential fat or bone marrow embolisation, although clinically significant events are uncommon when IO access is used appropriately.
Device- or user-related issues such as incomplete deployment or failure to achieve medullary cavity penetration if the device is not positioned correctly or used contrary to its instructions for use.
Storage Conditions
Store the unopened device in its original sterile packaging at room temperature under normal clinic or warehouse conditions.
Protect from excessive heat, moisture and direct sunlight; follow any specific temperature limits stated on the packaging or instructions for use.
Do not use the device after the printed expiry date or if the sterile packaging is opened, damaged or compromised.
Single-use only: do not attempt to resterilise, reload or reuse the device after deployment or once packaging has been opened.
Recommended shelf life is typically up to 5 years from the date of manufacture when stored as directed.
Duration
Intended for short-term emergency intraosseous access, typically for minutes to several hours, until alternative definitive vascular access (peripheral IV or central line) is established or resuscitation is complete.
Onset
Intraosseous access can usually be established within seconds and in less than 60 seconds in trained hands, allowing immediate delivery of fluids and medications with flow rates comparable to peripheral IV infusion once correct needle placement is confirmed.
