Catalog Number 2N3350 |
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 12/28/2020 |
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 an unspecified quantity of non-dehp micro-volume extension sets leaked.The event was further reported the leak were observed at the filter.The event occurred during an unknown 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: d9, h3 and h6.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The sample underwent pressure and clear passage testing and no blockage was noted.However, during pressure testing at 45 psi a leak was observed in the air vent of the filter.The reported condition was verified.The cause of the condition could not be determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information for h10: based on further investigation, the most probable cause was determined to be related to the end user/methods exceeding the product pressure specifications of 45psi.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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