Catalog Number FNC3220N |
Device Problems
Failure to Prime (1492); Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 the tubing of a clearlink continu-flo blood recipient set was bent over in the packaging and could not be primed.This issue was identified during priming.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information was added: the actual sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Gravity testing was performed with no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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