Catalog Number JC8723 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device manufacturer address 1: (b)(4).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 an unspecified quantity of clearlink system y-type blood/solution sets leaked between the injection port and the surrounding plastic.This was identified during setup, and preparation.There was no patient involvement.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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