Catalog Number H938740 |
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.The device was manufactured at one of the following manufacturing locations: (b)(4).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 two (2) 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were 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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Additional information was added to h6.H10: 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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