Catalog Number 114746L |
Device Problems
Fluid/Blood Leak (1250); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that during priming, three (3) units of revaclear 400 had a fluid leak at the fluid ports, due to the caps not creating a seal when screwed on (this was further described as the fluid ports were not screwing on and continually turning).There was no patient involvement.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.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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