Integra has performed a thorough review of the reported incident.There was no product received back, as such only a device history record (dhr) review was conducted.The dhr review concluded there were no assembly component related failures at the time of release.With the information provided, a root cause could not be reliably determined.
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Product was received for evaluation and had the bioset cap pressed down with the red mark showing in the vial (this is not how it is indicated in the instructions for use, the red mark should not be showing for the solution not to spill going in or out of the peg vial).The grommet was perforated by the bioset spike.There were traces of blue solution observed inside the vial.There was blue solution on the outside of the bioset, the solution was also spilled between the spike and the rubber grommet, indicating that the product had leaked.All 3 spray tips were received back along with the y-connector, they showed no traces of blue peg.The dhr review and product analysis of the polymer kit concluded there were no assembly component related failures with the returned product or at the time of release.The investigation was able to determine a root cause as the bioset on the vial not activated according to ifu.If the red indicating line on the bioset is still showing, the solution will spill going into the vial to reconstitute, or when drawing back the reconstituted solution.The reported condition was confirmed.The file will be closed as user error.
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