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Catalog Number 2C2008K |
Device Problem
Backflow (1064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device has been received and the evaluation is in progress.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 large volume infusor had backflow.This issue was discovered during use by the pharmacist.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was received for evaluation.A visual inspection was performed using the naked eye found fluid inside the bag that contained the sample.Functional testing was performed by filling the device with green colored water.During and after fill, no evidence of leak was observed at the fill port or at other parts of the sample.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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