Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Block b3: date of event: date of event was approximated to on (b)(6) 2018 as no event date was reported.Block f10; h6: device code of 1444 captures the reported event of seal compromised.Block h10: product analysis: a visual evaluation of the returned advanix pancreatic was performed.The device returned in its original pouch completely sealed, the pouch did not present holes or cuts that could compromise sterility; however, brown dust was found in the corners of the pouch (on the outer side of the seal); consequently, not confirming the reported complaint.Based on the product analysis, it was confirmed that the pouch and components are free of foreign material.During the manufacturing inspection, it was detected the damage found in the pouch.However, it is most likely that handling and manipulation of the device during shipping/storage could have contributed with the encountered brown dust issue, since, this condition indicates that likely the device was incorrectly transported or storage in the field, therefore, the most probable conclusion code for the encountered issue will be documented as cause traced to transport/storage since problems traced to the inappropriate transport or storage of the device.Therefore the most probable root cause for this event is no problem detected', since the device complaint or problem cannot be confirmed.Dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
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