Root cause: the sample was not returned for evaluation because it was discarded.Therefore, a true root cause is unable to be determined.However, a potential root cause has been identified.Specifically, a one-time change order was completed to swap gown components in the convenience kit.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary: an internal complaint (call 50334) was received indicating that a surgical gown contained in a c-section kit (finished good 89-9416) was not impermeable and allowed fluid to soak through the gown.The sample was not available as it had been discarded.Initially, a lot number of 562175574 was reported.However, this is incorrect.The correct lot number was identified as 52175574.The work order was reviewed for discrepancies that may have contributed to the reported issue.During this review, it was identified that a one-time change order was completed for the reported lot.Specifically, one gown part was removed and replaced with the gown involved in the reported incident.This was done at the sales representative's request.This gown was only used for the one-time change order and is no longer included in the convenience kit.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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