The sample was received in a plastic bag with medical band.On the band was placed a shunt.The sample was without scratches or damages.Some residues were observed on the sample.The lumen was clogged.After a cleaning, the lumen was open.No other complaints for the lot.All products pass 100% final inspection prior to approval.If a defect would be noticed, the product would have been rejected.The root cause is inconclusive - unable to verify, since the blockage could have been caused by many different reasons during the clinical procedure.However, the complaint on blockage is confirmed.The blockage does not seem to be product related since after cleaning the device - the blockage was removed.Additional information was provided in d.10., h.3., h.6.And h.10.The manufacturer internal reference number is:(b)(4).
|