H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), applicable fmea documents, applicable manufacturing records, returned sample analysis, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak at the y-injection site was confirmed.One safestep huber needle set from batch # asens0063 was returned for evaluation.A visual evaluation showed no signs of damage.A functional test of the returned device revealed that the extension set tubing was patent to infusion and aspiration.Upon pressurizing the safestep infusion set, a small drop of water was visible at the y-site along the edge of the blue valve stem.A microscopic examination of the y-injection site valve revealed that the blue stem moved slightly according to the pressure to which it was exposed.A positive pressure caused the top of the stem to extend slightly from the white valve cap and any fluid that was positioned between the blue valve stem and the white valve cap appeared to be pushed out.No fluid bypassed the sealing edge of the blue valve stem during aspiration or infusion.Subjecting the infusion set to a sustained positive pressure revealed no continuous leaks at the y-site.Likewise, while the device was under a sustained negative pressure, no air entered the infusion set during aspiration.The product ifu warns, ¿needleless y-injection site valve may leak slightly at certain pressures resulting in a small bead of fluid on the valve.¿ h3 other text : evaluation findings are in section h.11.
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