Catalog Number 2C4711K |
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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(b)(6).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 two (2) small volume folfusors leaked.The devices were filled with 4450 mg/ 3500 mg of fuoruracil in 115 ml of 0.9% sodium chloride.This occurred prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was manufactured between june 18, 2019 and june 19, 2019.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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Manufacturer Narrative
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Additional information was added: two (2) devices were received for evaluation containing approximately 120 ml of fluid in their bladder/balloon.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The bag that contained the sample was dry.Functional testing was performed by filling the device with green colored water.After fill, the samples were being monitored until the next day.The next day, no evidence of a leak was observed.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph and it showed no evidence of a leak.The reported problem could not be verified or refuted.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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