Needle-free bag access device / needle-free connector (bag access port)
Certifications
CE conformity indicated on BD product pages and distributor listings (confirm current CE/UKCA certificate and scope with manufacturer/distributor)
Manufactured and labelled to comply with applicable medical device regulations in the region of sale (verify with local distributor/IFU)
CE conformity indicated on BD product pages and distributor listings (confirm current CE/UKCA certificate and scope with manufacturer/distributor)
Manufactured and labelled to comply with applicable medical device regulations in the region of sale (verify with local distributor/IFU)
Needle-free bag access device / needle-free connector (bag access port)
Description
The BD SmartSite™ Bag Access Device is a needle-free valve bag access port designed to permit safe access to IV bags for addition or removal of fluids without opening the fluid path. The SmartSite™ system is intended to reduce needlestick risk, provide a smooth, swabbable surface for aseptic access, and integrate with BD Alaris™ pump sets, Texium™ closed male luer components and compatible infusion sets.
Bnefits
Needle-free access port: reduces risk of needlestick injury when accessing IV bags
Swabbable, smooth surface for disinfection prior to each access
Integrates with BD infusion systems (e.g., Alaris™ pump sets, Texium™ closed male luer) for a closed system workflow
Multiple configurations available (add-on with spike adapter, unvented spike variants) to suit clinical workflows
Manufactured without natural rubber latex, DEHP and PVC in specified configurations (reduces allergy and plasticiser concerns)
Indications
Access of IV/administration bags to add diluent and/or medication and to enable fluid changes without opening the primary fluid path
Use as part of IV administration sets, secondary sets, pump sets, or with BD SmartSite™ bags where indicated
Composition
Medical-grade polymer components (specific material formulations vary by configuration)
Manufacturer statements indicate select SmartSite™ configurations do not contain natural rubber latex, DEHP or PVC
Formulation
Needle-free valve / bag access port supplied as add-on bag access devices or assembled within BD SmartSite™ bags/sets; available in pack quantities (e.g. 100 per box) depending on configuration
Packaging
Bulk/retail packaging varies by distributor — example pack: 100 devices (quantity per box varies by catalogue item and region)
Each device is supplied sterile and individually packaged when sold as single devices or supplied in manufacturer packaging when sold as sets (refer to supplier carton labelling and IFU)
Usage
For single-patient, single-use only unless otherwise specified in the product IFU; dispose after intended use according to local protocols
Aseptically swab the access port with appropriate disinfectant (e.g., 70% isopropyl alcohol) prior to each access as per local policy and the device IFU
Connect to compatible female luer or spike adapters per BD instructions for use (IFU) to maintain a closed system
Follow standard aseptic technique and institutional infection control guidance when accessing bags
Contraindications
Do not use if packaging is damaged or sterility is compromised
Not intended for multiple-patient reuse; consult product IFU for any reprocessing instructions (if applicable)
Avoid use where the device configuration is not compatible with the intended administration set or pump system
Adverse Effects
Possible device-related events reported in post-market surveillance and public databases include leakage, occlusion/flow issues, or difficulty flushing/flow restrictions in rare cases; clinicians should monitor for therapy delays or flow compromise and follow local incident reporting procedures
General risks when using IV access devices: infection if aseptic technique is not used, fluid loss or contamination if leakage occurs
Storage Conditions
Store in original, unopened packaging in a cool, dry place away from direct sunlight and sources of heat
Follow any additional storage temperature and shelf-life information provided on the product carton or IFU
Duration
Not applicable (accessory device used as needed during IV therapy)
Onset
Immediate \u2014 provides immediate sterile access point when assembled/connected as directed
