(b)(4).The customer returned one epidural catheter, one snaplock adapter, and one non-teleflex cap for investigation.The returned components were visually examined with and without magnification.The components were received connected together.Visual examination of the returned catheter revealed that the catheter appears used.The catheter body appears to have been stretched slightly at the proximal end as the coils are misaligned.No other defects or anomalies were observed.Visual examination of the returned snaplock adapter revealed that a non-teleflex cap is attached to the female luer of the snaplock adapter.No other defects or anomalies were observed.Functional inspection was performed on the components as received using a lab inventory 20 ml syringe filled with water.The distal tip of the catheter was placed inside a measuring cup to catch any potential occlusion that could be pushed out during injection.The syringe was connected to the white non-teleflex cap and hand pressure was applied to the syringe.No injection was made.Further examination of the returned white cap revealed that there is no hole through the cap to inject through.Other remarks: the cap is not a teleflex product so it is unknown what the intended design is.The cap was removed and a second attempt was made to inject through the snaplock adapter and catheter.Upon application of hand pressure to the syringe, water was immediately seen exiting the distal tip of the catheter.No resistance was met.The water caught in the measuring cup was visually examined with no evidence of occlusion that was pushed out.The returned catheter and snaplock adapter were then connected to the lab leak tester ((b)(4)) and pressure was increased to 10 psi to establish flow.Water was found to immediately exit the distal tip.No blockages were detected.No lot number was provided.A device history record review was performed based on a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as the complaint could not be confirmed.No functional issues were found with the returned sample.The reported complaint of a blocked catheter was not confirmed based upon the sample received.The returned catheter and snaplock adapter were tested as received in their assembled state with no blockages detected during a manual flow text or a pressurized flow test.No lot number was provided.A device history record review was performed based on a lot number from sales history data.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.No functional issues were found.No further action will be taken.
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