(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, e-17019-100d; rev.02, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance the catheter more than 5 cm.Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting." the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position." other remarks: a corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of catheter kinking and being difficult to remove could not be determined based upon the information provided and without a sample.
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