ST PAUL CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
|
Back to Search Results |
|
Catalog Number 100/491/718 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/03/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that upon use, the rotating luer lock of the filter disconnected.No patient injury was reported.
|
|
Manufacturer Narrative
|
The device was received to perform an investigation.A visual inspection of the returned product found no issues related to the reported problem.It was not possible to conduct liquid flow test as the component had been used.A device history record (dhr) review found no observations in relation to the reported issue.As no issues were found with the received device, no root cause could be determined.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
|
|
Search Alerts/Recalls
|
|
|