(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 the epidural catheter with no evidence to suggest a manufacturing related cause.The customer returned one epidural catheter and one epidural catheter piece for investigation reference files (b)(4).The returned catheter and catheter piece were visually examined with and without magnification.Visual examination of the returned catheter revealed that the catheter appears used.Adhesive residue is present on the catheter body exterior and the catheter body is kinked at several locations.The catheter is not separated.Both the proximal and distal tips were confirmed to be present.Visual examination of the returned catheter piece revealed that the piece is from the catheter's proximal end.The point of separation indicates that the catheter has been cut.The coils remain tightly wound with no stretching visible in the extrusion or inner coils.The rest of the catheter was not returned.No other defects or anomalies were observed.The returned catheter was measured using a other remarks: calibrated ruler ((b)(4)).The returned catheter measures approximately 91.4 cm which is within specification of 88.5-91.5 cm per graphic kz-05400-002 rev.08.The catheter was returned in its entirety.The returned catheter piece measures approximately 4.4 cm.At least 84.1 cm of the second catheter was not returned.Specifications per graphic kz-05400-002 rev.08 were reviewed as a part of this complaint investigation.The ifu for this product, e-17019-100c rev.01, was reviewed as a part of this complaint investigation.The ifu for this product warns the user "do not alter the catheter or any other kit/set component during insertion, use, or removal." the point of separation on the catheter piece indicates that the catheter has been cut.No signs of stretching were present in the coils or extrusion.A corrective action is not required at this time as the condition of the sample received indicates that user error caused or contributed to this event.The reported complaint of a catheter separation was confirmed based upon the sample received.The returned catheter piece was confirmed to be the separated proximal end of the epidural catheter.The damage observed at the point of separation indicates that the catheter has been cut.The ifu for this product instructs the user, "do not alter the catheter or any other kit/set component during insertion , use, or removal." 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, based upon the damage at the point of separation, use error caused or contributed to this event.
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