The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/5/2021.H.6.Investigation: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one photograph which displayed a circle around a black dot on the catheter or needle cover.One retracted unit along with the catheter, needle cover, and opened package were also received.Upon inspection of the device, it was found that a black speck was present on the catheter tubing.The foreign matter was microscopically inspected where it was observed that the foreign appears to be imbedded in the surface of the catheter tubing or covered in silicon lubrication.Upon scraping the foreign matter, it was found that the foreign matter was only covered by silicon lubrication.Based on the visual and microscopic evaluation of the foreign matter an origin could not be determined.The unit was sent for further testing.The results confirmed the foreign matter to be poly(ester urethane).Although the defect was confirmed, a specific root cause could not be determined.However, as the foreign was found underneath the layer of silicon lube it was most likely introduced prior to the lubrication process.Based on the historical data, the defect is uncommon and is considered incidental.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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