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.Based on a review of applicable information, the following was concluded: the complaint that air was able to enter the infusion set was confirmed and the damage appeared to be supplier related.Three 22g safestep infusion sets with y-injection site were provided for investigation.A functional test revealed that air could enter two infusion sets through the y-site during aspiration.No continuous leak of fluid was observed in any part of the returned samples when the infusion sets were pressurized.The affected valves were cut open and the valve stem was removed, which revealed flow lines in the sealing surface of the valve stem and pitting in other areas of the valve stem.The damage to the sealing surface of the valve stem was located in an area that was inaccessible to the user.The uneven areas of the valve stem sealing surface most likely allowed air to bypass the valve during aspiration.Bd is working closely with the supplier to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
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