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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 12/03/2021 |
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 a small volume infusor stopped delivery during a patient infusion.This was further described as, ¿shortly after the infusion had started, the device stopped flowing¿.The device was being used to deliver an unspecified medication at the hospital.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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Additional information was added to h3, h4, h6 and h10: h4: the device was manufactured from november 17, 2020 - november 18, 2020.H10: the device was received for evaluation containing approximately 62ml 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 was visually observed 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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