Catalog Number 2C4700K |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter last name: (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 two (2) small volume folfusors under infused.This occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10.The actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the flow rate was found to be within the product specification range.The reported condition was not verified.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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