The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of advancing the picc the stylet indicator seems to be staying in the corner before crossing the scilla.The diamond will show up there as well when the picc is down in the svc is inconclusive as the reported issue could not be reproduced during evaluation.The device was serviced, tested and returned to customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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