The reported event was confirmed.Visual evaluation of the sample noted one opened unused piston syringe.No cap(cm1880) was noted to be on the syringe tip, but an adaptor was included within the syringe barrel s intended.Missing components are not allowed per procedure.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be error of inspector.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "caution: secure tip tightly prior to use." correction: d4.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.
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