Aspen surgical received a report from the distributor indicating that product was discovered with the dressing trapped in the seal.The actual device was returned for evaluation.The manufacturing lot numbers were also provided for review.The dhr and analysis results were reviewed.All samples passed acceptance criteria.No non-conformance's were noted related to the reported issue.From the sample provided, the issue was confirmed for product in the seal.The parts are placed onto a packaging line by a guide feed system.If not properly setup, it leads to miss feeding of parts.Along with the guide there is a roller feed that guides the product placement, so the seals and cuts can be properly placed.If the alignment is not set properly, the seals will not be formed.Machine setup is manual that requires to be adjusted for each product.Therefore, the root cause is due to operator error and misaligned tooling.Operations team has been notified of the reported problems along with manufacturing engineers.Additionally, the ifu which is received with the product, along with the pouch label, identifies this failure mode with the symbol "do not use if package is damaged".This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised.Based on this information, no further action is required.
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