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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This event occurred on an unspecified date in (b)(6) 2018.The device was discarded by the customer; 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 3000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking.It was further reported that the leak was over the letter "i" in the word mexico on the bag.This event occurred in the pharmacy.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 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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