Catalog Number 689311/B |
Device Problem
Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 06/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that when flushing the pressure monitoring set with force after collecting a blood sample, blood and saline would leak from the blood draw septum.No patient injury to report.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.
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Search Alerts/Recalls
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