Concomitant medicall products - device available for evaluation and h6 - evaluation codes: updated.Device evaluation: twenty unused devices, in their original packaging completely sealed, were returned for investigation.Visual inspection and functional testing found no faults or defects.The complaint could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective action is required as there is no information if the product leaks in the pre-check, which is listed in the instructions for use.
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