BD Vacutainer® Multiple Sample Luer Adapter

The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use blood collection device that connects to BD Vacutainer® needle holders and enables blood collection from venous access devices (needles, blood collection sets, catheters) into blood collection tubes or blood culture bottles for in vitro diagnostic testing. It is intended for use by healthcare professionals.

The device consists of a luer-slip fitting (male) that mates with female luer connectors, a lubricated non-patient cannula with a protective sleeve, a polystyrene hub, stainless steel cannula, isoprene rubber sleeve, polypropylene and high-density polyethylene shields, and epoxy adhesive. It is sterilized by gamma irradiation to achieve a sterility assurance level of 10⁻⁶ with a 3-year shelf life.

EN ISO 13485, EN ISO 14971, EN ISO 80369-7, EN ISO 9626, ISO 11607 (packaging), EN 556-1 (sterilization), EN ISO 11137 (radiation sterilization), ISO 11737 (microbial methods), EN ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility), and EN ISO 15223 (labeling symbols).

The subject device is substantially equivalent because it has the same intended use (blood collection from venous access devices), incorporates similar design and materials as the predicate K991088, maintains identical sterility assurance level and shelf life, and uses similar scientific principles and operating technology. The two differences identified—sterilization method (gamma irradiation vs. ethylene oxide) and non-patient shield material additive formulation—do not raise new questions of safety or effectiveness because both methods achieve the same sterility assurance level and the base resin composition remains unchanged. Comprehensive non-clinical performance and biocompatibility testing validates equivalent performance.