No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.After unlocking the connector, we re-plugged the catheter and performed a catheter pull-out test, and the results met the standard.The reported event was not confirmed.The root cause was not identified.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
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