Catalog Number H938741 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Event date: the event occurred on an unspecified date in 2019.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 3000mleva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was defective.The defect was further described as a leak coming from an unknown location.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H4: the lot was manufactured from april 26, 2019 - april 28, 2019.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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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Manufacturer Narrative
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Correction to b2: outcomes attributed to ae ¿ removed ¿congenital anomaly¿ as there was no adverse event or congenital anomaly involved in this report.(previously selected ¿congenital anomaly¿ in error).Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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