Catalog Number H938737 |
Device Problem
Material Perforation (2205)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 an unspecified quantity of 250 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags had a pinhole midway on the bag.This was identified prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was 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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