Catalog Number JC-05400-B |
Device Problem
Infusion or Flow Problem (2964)
|
Patient Problem
No Information (3190)
|
Event Date 12/19/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
|
|
Event Description
|
The epidural catheter was inserted; the needle removed and a little bit of blood was in the catheter.The catheter was rinsed or flushed immediately but the catheter was blocked.The catheter was removed and replaced.The patient's condition was reported as unknown.
|
|
Manufacturer Narrative
|
(b)(4).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 a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.The potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.
|
|
Event Description
|
The epidural catheter was inserted; the needle removed and a little bit of blood was in the catheter.The catheter was rinsed or flushed immediately but the catheter was blocked.The catheter was removed and replaced.The patient's condition was reported as unknown.
|
|
Search Alerts/Recalls
|