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 a small volume folfusor leaked.The device was filled with 4450 mg of fluoruracil in 115 ml 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 from february 11, 2019 - february 14, 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: the actual device was received for evaluation.A visual inspection was performed using the naked eye found no evidence of leak on or the entire device.Functional testing was performed by filling the device with green colored water.After fill, the blue winged luer cap was hand tightened.The sample was being monitored until the next day and no signs of leak were 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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