We connected our stocked catheter and the connector and performed a catheter pull-out test according to manufacturer's standards of overseas manufacturers, but no catheter removal from the connection was confirmed.Based on the above test results, the product conformed to the product standard, and no abnormality was found that could lead to this event.Because the event was not reproduced, it was not possible to identify the cause.No lot number was provided; therefore, device history record review could not be completed.D4 udi is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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