Conclusion codes: updated device evaluation: one used, decontaminated device was received for investigation.Visual inspection noted a piece of suction line tubing was still inside the connector (bonded with the connector).The suction line tubing was separated from connector near the connector entrance.The device was sent to a second investigation site for further root cause analysis.At the second investigation site only the connector was received, the connector was detached from the tube and a piece of tube was identified inside the connector, confirming the complaint.Based on the analysis conducted in the sample and photos provided of the sample, the occurrence of this failure condition could be caused by the incorrect use of the product, since a portion of the suction line tubing remains inside the connector, indicating that the union was correct and due to an external force, the tubing was pulled out of the connector.A review of the device history record (dhr) could not be completed as no lot number was provided.No corrective actions are required since the main cause of the detachment problem is improper use of the product.
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