Evaluation summary because no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of the photo was performed.The sample showed signs of use and revealed the arterial adapter (red) was disconnected from the tubing.According to the instructions for use (ifu), the customer must perform an inspection before using the device.The ifu also states to not infuse against a closed clamp or forcibly infuse a blocked catheter because backpressure could force the adapter out of the tubing.As part of the investigation process, the reported condition was analyzed, and an attempt was made to replicate it.Based on this replication of the reported condition and the instructions for use (ifu) it was confirmed that if the extension clamp was closed and a pressure was inserted, the backpressure would force the adapter out of the tubing.The reported condition has been confirmed.With the available information there is no enough evidence to relate this event with the manufacturing process.No triggers or trends were identified, and this is not a manufacturing related event, therefore, no corrective or preventive actions are required at this moment.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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