Catalog Number 2N8374 |
Device Problems
Reflux within Device (1522); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/02/2019 |
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 that blood was observed in a clearlink catheter extension set.When the set was replaced, the silicone hub was found protruding outward.This was noted during patient infusion using an unspecified pump.There was no 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 : only the luer activated valve was received for evaluation.A visual inspection was performed which revealed a hard piece of plastic coming out of the inlet housing.It was also observed that the slit was broken.The reported problem was verified.The cause of the condition was not determined.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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