Catalog Number 4505000000 |
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 5 devices were received.6 device investigation types have not yet been determined.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.- 11 events had no patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h6, h10 11 previously reported events are included in this follow-up record.Product return status 11 devices were received.
|
|
Event Description
|
This report summarizes 11 malfunction events in which the device was reportedly leaking.- 11 events had no patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|