Catalog Number 5400210060 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 5 malfunction events in which the device was reportedly leaking.4 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 5 events were reported for this quarter.Product return status 5 devices were received.Additional information 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
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Search Alerts/Recalls
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