Catalog Number JC8723 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device manufacturer address: (b)(6).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 the injection port of a clearlink system y-type blood/solution set was leaking.This issue was identified during an unspecified process step.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 h6.H10: the device was not returned and the lot number is unknown; 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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