BAXTER HEALTHCARE CORPORATION SPIKE, UNIVERSAL, LL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93829 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that the vent of a luer lock universal spike came all the way out, causing fluid to leaked from the attached bag.This issue was identified before use.There was no patient involvement.No additional information is available.
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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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Manufacturer Narrative
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H4: the device was manufactured on april 05, 2023, to april 06, 2023.H10: 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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