Catalog Number 2C8857 |
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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The date of the event was reported as either (b)(6) 2021 or (b)(6) 2021.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 a vented paclitaxel set leaked.The leak was observed from the ¿white connector piece near filter¿.It was further reported, the cause of the leak appeared to be from ¿damaged tubing¿; it was ¿almost like the white band was crimped too much and weakened the tubing¿.The issue occurred during setup.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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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 discarded; 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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