D4 expiration date - added.H4 manufacturing date- added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging and device was prepared for use as per the directions for use.Also, continuous flush was set up and maintained throughout the clinical procedure thus, as the device was not returned the probable reason could not be determined.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of 'undeterminable' was assigned.
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