Catalog Number H938742 |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 an exactamix eva total parenteral nutrition (tpn) bag had a pinhole along the side seam near the top of the bag which resulted in a leak.This event was discovered during setup and before use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was received for evaluation.A visual inspection was performed and a small tear in the top left side seam of the bag was observed.A functional leak test identified a leak in the top left side seam of the bag.The reported condition was verified.The cause of the reported 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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