Catalog Number H938737 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Premature Labor (2465)
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Event Date 01/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility submitted a medwatch report for this event: mw5083495.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 three (3) 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked around the tubing spike port.The devices were filled with 145ml of unspecified solution.The leaks were noted during filling.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The devices were 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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