SmartSite™ Bag Access Device (Pack of 100)
Becton Dickinson
Medical device / IV therapy accessoryNeedle-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
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