Balt usa reference (b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this compaint the device failed to meet its performance specifications according to the initial claim submitted by the user.For these complaints, the potential harm did not lead to a serious injury or death, however the performance specification which was failed to be met for these complaints could have led to a serious injury or death based on the initial information that was reported to balt.The returned device was inspected in our quality laboratory.During our analysis: - we noted that the returned device pouch was opened; - we observed no abnormalities along the pouch seal; - we observed no puncture holes throughout the pouch.Root cause of the packaging issues endured by the coil system can not be definitively determined.Upon return of this device, it was observed that the pouch was already opened.Further investigation showed that there were no visible abnormalities along the pouch seal, indicating proper closure of the aforementioned pouch.Moreover, no puncture holes were seen throughout the pouch.Per lhr, 100% inspection was conducted, with qc final inspection and pouch inspection approval.It is unknown how or when packaging damage occured.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f200300272 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
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