The device was not returned for evaluation, however the lot files for this device wer reviewed.It was determined that during assembly, a note on the drawing requiring a certain label to be added to the "pigtail" components, was missed by the operator and the inspector.In order to address this issue, capa (b)(4) was initiated and assemblers re-trained.The customer also reported lines that were not connected.A review of the drawings and lot files showed that the lines reported were connected as required during manufacturing.Further communication with the facility revealed that the connection the customer was referring was actually lines 5 and 7.A review of device drawings showed that these lines are not meant to be connected.Therefore the kit was assembled per specification and no further action was required.A review of complaint history did not reveal any similar issues reported for these kits.(b)(4).
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