Catalog Number 2R8401 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/23/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The user facility submitted medwatch (b)(4) for this event.Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that an unspecified quantity of clearlink system, non-dehp solution sets leaked chemotherapy medication.It was not specified when in the process step this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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
|