(b)(4).The customer returned one opened cvc kit for evaluation.No definite signs of use were observed.Visual analysis revealed that the kit tray was severely damaged and the lidstock was not entirely sealed to the tray.Observation of the tray revealed that the tray adhesive seemed sparse in certain locations of the flange, but further consultation with the packaging facility confirmed that the amount of adhesive was acceptable.Severe damage to the tray both on the body and along the edges was also noted.The ars tip was observed to be damaged.Due to the extensive damage, clarification was requested from the customer to provide additional details and they confirmed that the kit wasn't entirely sealed and that the "tray was severely crushed/deformed".This, they stated, also likely contributed to the observed ars damage.The packaging and distribution facilities were consulted as part of this complaint investigation.Packaging stated that the adhesive observed on the tray was an acceptable amount based on a heat seal visual inspection conducted.Therefore, it likely would not contribute to the damage.Damage to the chinese label on the lidstock was also noted.The distribution facility stated that the damage could be present during transportation or labelling, but not during operations in the distribution center.A device history record review was performed, and no relevant findings were identified.The customer report of a damaged kit seal was confirmed through investigation of the returned sample.Visual analysis revealed that the kit tray was severely damaged.The packaging and distribution facilities were consulted, and they stated that the damage is more consistent with the transportation during shipping and storage.Therefore, based on the customer report and sample received, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
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