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 10/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility submitted a medwatch report for this event: mw5081220.The device was not received for evaluation; therefore, a device analysis could not be completed.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 a 3000 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from the center port, at the ridge.The leak was discovered during compounding.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were 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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