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Reported issue: we have had a few catheters that were not patent (not allowing flow of medication) and had to be replaced.I have kept a few of them along with their lot numbers.The patients were fine, except for the second procedure.I do not think any of them came back with pdph.Four that i know of i have heard rumors of a few others but i never saw an rl6 or got confirmation from the performing provider.We replaced the catheters with working catheters.Since then we usually check the catheter prior to placement but this is inconsistent.The lot numbers on the two i kept are both 23f20g0141.Unfortunately, i do not have the lot numbers for the rest.
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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 was blocked.The customer returned one 20ml luer-lock injection syringe, one snaplock assembly, one epidural catheter, and lidstock.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned syringe 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.Biological material can be seen between the inner coils especially at the distal end.Also, the catheter appears to have been cut at the proximal 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 77.5cm.This indicates at least 11cm of the extrusion is missing as the specification for the epidural catheter, indicates the proper extrusion length of an epidural catheter is 88.5-91.5 cm per graphic kz-05400-021 rev.4.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.8.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester (ref-002902) and the pressure was increased to 10 psi to establish flow.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock assembly and lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating there are no flow issues with the returned snaplock assembly.An attempt was made to thread a lab inventory wire through the epidural catheter.However, this could not be performed based on the distal tip being a closed tip multiport.Also, since the proximal end of the returned catheter was cut, a lab inventory wire could not be inserted based on the inner coil wire being damaged.Specifications per graphic kz-05400-021 rev.4 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 cautions the user," do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." 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 being blocked was confirmed during functional inspection of the returned sample.The returned epidural catheter was found to be completely occluded with biological material.Microscopic examination of the returned catheter indicated a heavy presence of biological material between the catheter's inner coils at distal end.An attempt to thread a lab inventory wire through the returned epidural catheter could not be performed based on the distal end being a closed tip multiport and the proximal end inner coil wire being damaged based on the catheter appearing to have been cut.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.It is unknown how the catheter was handled prior to and during use.Therefore, the potential cause of the catheter being blocked could not be determined.Teleflex will continue to monitor and trend reports of this nature.
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Reported issue: we have had a few catheters that were not patent (not allowing flow of medication) and had to be replaced.I have kept a few of them along with their lot numbers.The patients were fine, except for the second procedure.I do not think any of them came back with pdph.Four that i know of i have heard rumors of a few others but i never saw an rl6 or got confirmation from the performing provider.We replaced the catheters with working catheters.Since then we usually check the catheter prior to placement but this is inconsistent.The lot numbers on the two i kept are both 23f20g0141.Unfortunately, i do not have the lot numbers for the rest.
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