Catalog Number 2N8399 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2021 |
Event Type
malfunction
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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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Event Description
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It was reported an unspecified quantity of clearlink luer activated valves leaked.It was further reported during ct/mri the ivs are having "blow outs".The events occurred during "high pressure contrast studies".It was further reported the clearlink luer activated valves are not recommended with high contrast injections.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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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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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