A flashing test was performed prior to insertion of the catheter and no problem was confirmed at that time.However, after placement of the catheter, the medical agent did not go through the inserted catheter so the catheter was replaced by a new one.There was no patient injury.
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(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter is blocked.The customer returned one snaplock adapter with clip, one flat filter, and one epidural catheter.The snaplock adapter, flat filter, and catheter were received connected together (reference attached files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned flat filter revealed the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen within the inner coils of the catheter and adhesive material can be seen on the outer extrusion of the catheter.No other defects or anomalies were observed.A manual flow test was performed using the returned components.A 20ml lab inventory syringe was connected to the returned flat filter, the returned other remarks: snaplock adapter, and returned catheter.Using hand pressure, the water was injected.Water could be seen immediately exiting the distal end of the catheter.No blockages were found.The reported complaint of the catheter was blocked could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test.There were no functional issues found with the returned sample.
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A flashing test was performed prior to insertion of the catheter and no problem was confirmed at that time.However, after placement of the catheter, the medical agent did not go through the inserted catheter so the catheter was replaced by a new one.There was no patient injury.
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