(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter "migrated" from the patient.The customer also stated after the catheter migrated, the catheter looked extended (stretched).The customer returned one flat filter nrfit, one snaplock assembly nrfit, and one epidural.The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed both components appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used as adhesive can be seen on the outer extrusion.The returned catheter also appears to be slightly stretched at the distal end.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (10171599).The returned catheter extrusion measures approximately 90.8cm.The extrusion and coil wire appear to be slightly stretched at the distal end of the catheter.Even with the slight stretching, the catheter is still within the specification of 88.5-91.5 cm per graphic kz-05400-030 rev.04.Specifications per graphic kz-05400-030 rev.04 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.7, 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.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the catheter stretching during use was confirmed based upon the sample received.Visual examination of the returned catheter revealed the distal end of the catheter appeared to be slightly stretched.The ifu for this product warns the user never tug or quickly pull on catheter during removal and do not apply additional tension if the catheter begins to stretch as there is a risk for separation.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.It is unknown how the catheter was handled prior to and during use.Therefore, the potential cause of the catheter stretching could not be determined.
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