The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of infusion set malfunction was confirmed; however, the root cause was not identified.The product returned for evaluation was one 22ga x 0.5¿ safestep safety infusions set with y-site.The sample was received with the safety mechanism engaged.No obvious use residues were observed.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, during aspiration, some air was withdrawn into the syringe.The air aspiration was isolated to the valve by clamping the sample at various points on both extension tubes.Microscopic inspection of the valve septum revealed a gap between the valve septum and the valve housing.Inspection of the septum revealed deformation that appeared consistent with mechanical damage.The gap between the valve septum and housing may have caused/contributed to the observed air aspiration.The septum features suggested that mechanical damage may have contributed; however, the source of that damage/gap was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of asezf011 showed no other similar product complaint(s) from this lot number.
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