Catalog Number 2C4711K |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a "substance was in the thread" of a small volume folfusor.The device was filled with 3150 mg of fluoruracil in 115 ml of 0.9% sodium chloride.This occurred prior to patient use.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
The device was manufactured between april 19, 2019 and april 22, 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.
|
|
Manufacturer Narrative
|
Additional information was added: the device was 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.
|
|
Manufacturer Narrative
|
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 particulate matter.The reported problem could not be verified or refuted.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|