Date of event: estimated the unique device identifier (udi) is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.Due to the limited information available, the investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.As multiple devices were captured in the pmcf report.Additional reports were filed under manufacturing reference numbers: (b)(4).Pmcf attachment title: post-market clinical follow-up evaluation report accessories and indeflators.
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It was reported through a post market clinical follow up (pmcf) evaluation report identifying the rotating hemostatic valve device that may be related to the following: leak, loose/intermittent connection, break, which could potentially lead to air embolism.Details are listed in the attached pmcf, titled post-market clinical follow-up evaluation report accessories and indeflators please see the attached post market clinical follow up evaluation report for specific information.
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