BD Plastipak™ Syringe

The BD Plastipak™ Syringe is a three-piece, single-use, sterile hypodermic syringe with a 6% (Luer) male connector available in 20 mL and 50 mL eccentric luer slip tip configurations. It is intended for use by healthcare professionals for general purpose fluid aspiration and injection, with components including a polypropylene barrel, synthetic rubber stopper, and polypropylene plunger rod, sterilized by ethylene oxide gas.

The subject device differs from the predicate (BD Single Use, Hypodermic Syringe) primarily in barrel resin material and supplier: the subject uses polypropylene (HPR35CMD) versus the predicate's polypropylene (PH-712B). The subject is available only in 20 mL and 50 mL luer-slip eccentric tip configurations, whereas the predicate offers 1–50 mL in multiple tip configurations (luer-lok, luer-slip, eccentric). All other components, sterilization method, shelf life, and packaging are identical between devices.

ISO 7886-1:2017 (breakout force, sustaining force, leakage past stopper, volumetric accuracy, dead space); ISO 80369-7:2021 (luer leakage, stress cracking, resistance to axial separation); ISO 10993-5:2009, 10993-10:2021, 10993-23:2021, 10993-11:2017, 10993-4:2017 (biocompatibility); ASTM F756-17 (hemolytic properties); USP43-NF38 <151> (pyrogen test).

The change in barrel resin material and supplier does not alter the device's intended use, operating principle (piston syringe), or performance characteristics. The subject device's 20 mL and 50 mL sizes fall within the predicate's range of available sizes. Comprehensive bench performance testing (force, leakage, accuracy, luer integrity) and biocompatibility testing (cytotoxicity, sensitization, systemic toxicity, hemocompatibility) all met predetermined acceptance criteria, demonstrating no new questions or modified risks of safety and effectiveness.