Catalog Number 515101250010 |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/23/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a 2.5mm flow coupler did not closed properly.The event was identified during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|