Model Number IPN046779 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/12/2021 |
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
|
Per the doctor catheter tip broke off when removing from patient and tip is still in patients epidural space.
|
|
Manufacturer Narrative
|
(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.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 the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was returned for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.
|
|
Event Description
|
Per the doctor catheter tip broke off when removing from patient and tip is still in patients epidural space.
|
|
Search Alerts/Recalls
|