Qn#(b)(4) the customer provided two photos for analysis.The first photo shows the packaging box label indicating the kits in the box should be eu-25853-cvt kits, with one of the kits next to it showing the lidstock, which reads "es-04730-ek", an incorrect material number.The second photo shows the contents of the kit labeled "es-04730-ek", which correspond to the contents included in eu-25853-cvt.The customer also returned 20 unopened cvc sets for evaluation.Visual inspection of the returned samples revealed the lidstocks on all returned kits are incorrect.The labeling on the returned boxes indicates the contents of the boxes should be kits with the material number eu-25853-cvt, lot number 71f22d1829, and contain a 3-l 8.5 fr.20 cm cvc.The lidstocks on the kits label them as es-04730-ek, lot number 71f22d2024, a s-l 14 ga.30cm cvc kit.The kit contents were further inspected, and they all contain the 3-l cvc that corresponds with the reported material, as well as all the required components per the bill of materials for eu-25853-cvt.Therefore, it was determined that the lidstocks attached to these kits were incorrect.A device history record review was performed, and the following relevant findings were identified: for material eu-25853-cvt, lot 71f22d1829, non-conformance was opened regarding an incorrect lidstock on the product.The customer report of an incorrect lidstock/pouch labeling was confirmed through complaint investigation of the returned samples.V isual inspection revealed the kit lidstocks did not match the material and lot numbers on their respective packaging boxes.Moreover, the kit contents did not match the lidstock contents, but rather the labeling on the boxes.Therefore, it was determined that the lidstocks sealed to these kits were incorrect.Based on these circumstances, packaging caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
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