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.Observation of the connector revealed burrs inside the sleeve, indicating damage.The catheter did not show any abnormalities, such as stretching or damage.Next, the returned catheter was connected to the returned connector and a catheter removal test was performed in accordance with the product standards of the manufacturing site.The same test was performed by connecting a stock catheter to the returned connector, but the catheter was not held for the specified time and did not comply with the standard.To recreate the situation where the catheter was pulled out of the infuser pump, the catheter was disconnected from the connector with excessive force after connecting the connector to the stock catheter.After observing the inside of the sleeve of the connector, it was found that burrs were generated as in the returned connector.Therefore, it is highly probable that burrs or damage inside the connector occurred when the infuser pump dropped.However, we could not determine whether the connector complies with the standard.The root cause of the issue could not be determined.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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