Catalog Number H938740 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/13/2020 |
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 ten (10) 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking coming from a pinpoint puncture in the middle port with the winged twist off cap.This issue was identified after 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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H4: the lot was manufactured from (b)(6)2020 - (b)(6) 2020.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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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