Model Number IPN045606 |
Device Problem
Complete Blockage (1094)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
|
|
Event Description
|
I had an epidural kit with an epidural catheter with the tip still sealed.
|
|
Event Description
|
I had an epidural kit with an epidural catheter with the tip still sealed.
|
|
Manufacturer Narrative
|
Qn#(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 epidural catheter with no evidence to indicate a manufacturing related issue.The customer did provide a photo that appears to show an epidural catheter tip.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided.No further action is required at this time.
|
|
Search Alerts/Recalls
|