(b)(4).The customer returned one cvc kit for analysis.Visual analysis revealed that the bottom-right corner of the lidstock was peeled off the tray, which is not the intended assembly of the lidstock to the tray.Further analysis revealed that the remanence of the glue on the tray was splotchy and not uniform.This likely contributed to the sterility breach reported by the customer.Packaging facility was contacted as part of this complaint investigation.They confirmed that this is a packaging related defect.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed that the bottom-right corner of the tray was not sealed properly.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received and the comments from packaging, the root cause for this issue is packaging related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
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