Model Number IPN923994 |
Device Problem
No Flow (2991)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/22/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn#: (b)(4).The device has not been returned for investigation.
|
|
Event Description
|
We had two epidurals tonight that the catheters would not flush.We switched to 3 different caps.One epidural i cut the catheter with sterile scissors before the second window on the catheter and then it was able to flush.The other epidural catheter would not flush at all.It was removed and the patient declined a second epidural and then delivered.
|
|
Event Description
|
We had two epidurals tonight that the catheters would not flush.We switched to 3 different caps.One epidural i cut the catheter with sterile scissors before the second window on the catheter and then it was able to flush.The other epidural catheter would not flush at all.It was removed and the patient declined a second epidural and then delivered.
|
|
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 epidural catheter with no evidence to indicate a manufacturing related issue.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.
|
|
Search Alerts/Recalls
|