Returned for evaluation was an unopened evlt kit pouch for lot number 5734575.While reviewing the components, it was noted there was a kink on the tre-sheath (and its shipping tube), the dilator (and its shipping tube) and a crease of the pouch. in addition, contrary to the complaint description there was no damage to the fiber device.This failure mode does not meet the criteia for a reportable adverse event, however in order to close out the complaint record this medwatch is being submitted.The noted kink of the tre-sheath was 8cm from the tip and the noted kink of the dilator was 14cm from the tip.The customer's reported complaint description of a kit that had kinks in dilator and tre-sheath tubing (and their shipping tubes) was confirmed based on the sample returned.The root cause of the kinked tubing is likely damage due pouch and tubing being creased; potentially during transit and/or storage at the customer facility between shipment date of (b)(6) 2022 and event date of 26-oct-2022.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint. the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Manufacturing personnel 100% visually inspect devices during the packaging process. this type of tubing kink damage would be noticed prior to shipment.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
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