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Catalog Number J2C1702 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 the delivery of a small volume infusor stopped during patient infusion.The device was filled with 5fu 60ml and saline 22ml to a total fill volume of 82ml.After priming, the nurse confirmed two or more drops of the drug solution.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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The lot was manufactured between september 17, 2021 - september 18, 2021.The device was received for evaluation containing 82 ml of fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.After the luer cap was removed, evidence of continuous flow of fluid was observed coming out at the distal luer.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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