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Catalog Number 2C2702K |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2023 |
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 that there was unspecified damage to a small volume infusor which resulted in a fluid leak.This event was further described as, ¿the customer observed breakage with loss of fluorouracil¿.The leak was observed during preparation of the device prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H4: device manufactured on october 7, 2022- october 11, 2022.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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