(b)(4).Date sent to the fda: 08/03/2020.A manufacturing record evaluation was performed for the finished device am3659 number, and no non-conformances were identified additional h3 investigation summary: an unopened sample of product code 1129t, lot # am3659 was returned for analysis.During the visual inspection of the sample, the paper of overwrap packet was observed delaminated.A functional test was performed to the packet and the seal strength force met the requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the condition of the sample, the assignable cause of the packaging integrity is caused by delamination.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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