A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this product, cz-05400-108a; rev.02, was also reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.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." the ifu also provides alternate catheter removal techniques if difficulty is encountered and indicates "since any epidural catheter can inadvertently be separated if excessive force is applied during removal, clinicians must be aware of the importance of proper removal technique." 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.Other remarks: 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 being difficult to remove could not be determined based upon the information provided and without a sample.
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