(b)(4).Visual inspection could not be performed as no sample was returned for analysis.However, the customer did submit a photo.The submitted photo shows a damaged catheter that looks to have separated (reference files (b)(4)).The ifu for this kit, (b)(4), was 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 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." a corrective action is not required at this time.Although, the customer submitted a photo, a root cause could not be determined based upon the information provided and without a sample.Other remarks: complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.Although, the customer submitted of photo that show a separated catheter, the potential cause of the catheter being difficult to remove could not be determined based upon the information provided and without a sample.
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