Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code (b)(4).
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The returned sample was visually inspected.It was confirmed that there was a crack along the seam of the l-shaped connector in the sampling line.A review of the device history revealed no production related anomalies.Replication testing was performed on a retention sampling manifold line.The l-connector was over-tightened onto a port of the reservoir, which lead to the l-connector cracking along the part, in the same way as the returned sample.During setup of the circuit, the l connector had been overtightened, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
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