No lot number was provided; therefore, device history record review could not be completed.A catheter was received for evaluation.Visual and functional testing were performed.No visual abnormalities were found.Functional revealed that after unlocking the connector and being plugged into the stock catheter for the catheter pull-out test, the results met the standard.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.No information is available.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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