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 12/23/2020 |
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 reported three (3) non-dehp micro-volume extension sets leaked.The event was further reported the leak was coming from the tubing.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: h6.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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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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