Catalog Number H938741 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/29/2018 |
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 two (2) 3000ml exactamix eva (ethyl vinyl acetate) bags were leaking at the port.This event occurred during compounding.There was no patient involvement. no additional information is available.
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Manufacturer Narrative
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Two actual samples were received for evaluation with the spike port covers removed.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak from the spike port at the spike port cap of both samples.The reported condition was verified.The cause of the reported condition could not be determined.This issue is being further investigated.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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