Catalog Number ASK-05500-BCW |
Device Problem
No Flow (2991)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn# (b)(4).
|
|
Event Description
|
It was reported that after insertion, the epidural catheter was not able to be injected through.It was removed and was found to not have a functioning opening at the end.The issue was resolved by inserting a 2nd epidural catheter.There was no harm or injury to the patient.
|
|
Manufacturer Narrative
|
(b)(4).The customer reported the catheter was unable to inject.The customer returned one snaplock assembly, an 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 snaplock assembly revealed the snaplock appears 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.No other defects or anomalies were observed.A functional flow test was performed.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 and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 8.7ml/min, which is within the specification of 1ml/min minimum.No blockages were found.A device history record review was performed on the epidural catheter with no relevant findings.The reported complaint of the catheter unable to inject 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 and met flow rate specifications.There were no functional issues found with the returned sample.No further action is required at this time.Other remarks: n/a corrected data: n/a.
|
|
Event Description
|
It was reported that after insertion, the epidural catheter was not able to be injected through.It was removed and was found to not have a functioning opening at the end.The issue was resolved by inserting a 2nd epidural catheter.There was no harm or injury to the patient.
|
|
Search Alerts/Recalls
|