Catalog Number 2R8537 |
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 08/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Lot #: r18h04070 was reported as a suspect lot.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 tubing of a clearlink system; non-dehp continu-flo solution set was leaking.It was further reported that the leak occurred right below the lower most y-site on the iv tubing.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 h4 and h6.H4: the suspected lot# r18h04070 was manufactured from 08/06/2018 - 08/07/2018.H10: 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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