Lot number 1200875 was entered in d4 on the initial report in error.Customer was unable to confirm lot number and the packaging was not kept.Since no lot number was provided, we were unable to trace the device history record, quality testing performed and corresponding results.The nonconformance data since april 2021 to present was reviewed and no issues that could be related to the catalog number and condition reported were found.The actual customer sample was received for investigation inside of plastic bag, not its original package.Our visual examination of the returned product revealed it is a kit drain 100cc w/7mm perf as reported.Visual inspection of the returned product revealed that the clear silicone tubing broke.The microscopic examination revealed a wavy/jagged edge at the tubing fracture site.No indications of stretched tube were observed.The characteristic of the fractured area suggests that an instrument was used to handle the product.Per instructions for use, if the drain is implanted for a period that allows tissue ingrowth around the drain this can cause the drain to break during removal.In addition, instructions for use indicate that drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.Also, to facilitate removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured; either internally or externally.Do not suture the drain(s).The most probable root cause was identified as misuse by the customer since the wavy/jagged edge condition observed at the fracture area suggests that an instrument was used to handle the product.Use of an instrument to handle the product may have inadvertently damage the product thus leading to tubing breakage.As preventive actions, the customer will be provided with a copy of the instructions for use.It is recommended to strictly follow the instructions provided in the instruction for use (ifu) data included with the product to ensure drains are properly used.According to the instructions for use (ifu).¿drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.To facilitate removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured; either internally or externally.Do not suture the drain(s).Drains should be placed and removed carefully by hand only with a slow, steady pressure.Excessive force may result in breakage.During placement and removal of the drain, do not nick, cut, tear or otherwise damage the drain as this may lead to breakage.Leaving the drain implanted for any period of time which allows for tissue ingrowth around the drain and into the holes, may cause breakage on removal.¿ cardinal health will continue to monitor trends and utilize the information as part of continuous improvement.
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