Catalog Number 2B8071 |
Device Problems
Backflow (1064); Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/03/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a vial-mate reconstitution device was leaking outside the adapter and solution was backflowing into the vial.The leak was observed during reconstitution.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
Correction made to a1: patient identifier: none (previously submitted as unknown).Correction made to a2-a6: na (previously submitted as ni).Correction made to b5: there was no patient involvement (previously submitted as there was no report of patient injury or medical intervention associated with this event).Correction made to b6: na (previously submitted as ni).Correction made to b7: na (previously submitted as ni).Correction made to d10: na (previously submitted as ni).Correction made to f10/h6: health effect - impact codes: replace f26 with f27.Additional information was added to h6: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|