No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.A retained sample was evaluated.As a result of connecting an connector with a silicon ring in our stock and a syringe, it was confirmed that the silicon ring rebounded and it was difficult to connect with the syringe.The reported issue was confirmed.The root cause could not be determined; however, a possible root cause is likely to be related to a long silicon ring, which interferes with the connection of devices other than flat filters.Relevant departments were made aware of the information to investigate potential issues with the silicon ring design.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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