Catalog Number 5407200000 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/31/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 11 events were reported for this quarter.Product return status 11 devices were received.Additional information 11 devices were not labeled for single-use.11 devices were not reprocessed or reused.
|
|
Event Description
|
This report summarizes 11 malfunction events in which the device was reportedly leaking.- 10 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|