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Catalog Number J2C1711 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that a small volume infusor stopped medication delivery.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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Should additional relevant information become available, a supplemental report will be submitted.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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Manufacturer Narrative
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H4: the lot was manufactured october 26, 2022 - october 28, 2022.The device was received for evaluation.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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