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Catalog Number 2C1009K |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: 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 would not flow.This was observed during setup, prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The lot was manufactured between february 23 and february 25, 2023.The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph observed residual fluid inside the bladder which suggested a no flow may have occurred.The reported condition was verified.The cause of the 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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