(b)(4).No lot number was provided by the customer.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on epidural kit and saline ampule with a relevant finding.The digital master sample kit does not depict placement of the saline ampule in the protective sleeve.(b)(4) were reviewed as a part of this complaint investigation.A potentially relevant finding was discovered during a device history record review on the epidural kit.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.Complaint verification testing could not be performed as no sample was returned for analysis.No lot number was provided by the customer.A device history record review was performed based upon a lot number from sales history data.A device history record review performed on the epidural kit indicated a potential relevant finding that may have contributed this complaint issue.The digital master sample kit does not depict placement of the saline ampule in the protective sleeve.Although, a sample was not returned, based on the dhr review, the potential root cause of this complaint issue is design other remarks: related.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.
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