Catalog Number 2B8071 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that leakage was observed while using a vial-mate adapter.Fluid from a reconstituted medication was leaking out of the bag which a vial-mate adapter was attached.The leak appeared to be at the intersection of the blue and tan portion of the adapter.This issue was identified during setup/preparation prior to patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information : 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.
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Search Alerts/Recalls
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