Catalog Number H938742 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone no.(b)(6).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 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was defective.The defect was further described as 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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H10: the device was received for evaluation.Unaided visual inspection was performed which observed a small tear observed at the lower right side edge of the bag.A functional testing was performed which revealed a leak on the affected location.Additional magnified inspection was performed which verified a tear/hole where the leak coming from.The reported condition was verified.The cause of the condition could not be determined.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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