The reported event was confirmed however the cause was unknown.A stent was returned open in its original packaging with its pigtail straightener.The suture was not returned.No visual defects were found from 18-20 in.The sample was found to be in two separate pieces.The separation was found not to be at a port hole.According to the supplier evaluation the root cause was unknown, however supplier have taken steps to further ensure stents are not being shipped "broken", including an additional tensile testing an increase in sample sizes.A potential root cause could be due to "inappropriate package design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent".H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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