Catalog Number H938737 |
Device Problems
Fluid/Blood Leak (1250); Material Perforation (2205)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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 250ml exactamix, eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag had a pin-sized hole along the seam.This was identified during an unspecified process step.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.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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Search Alerts/Recalls
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