Catalog Number 1C8109 |
Device Problems
Fluid/Blood Leak (1250); Cut In Material (2454)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
This occurred on an unknown date in 2016.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a solution set had a cut in the tubing.This was found before patient use.It was stated that there was a leak from a slice in the tubing from the blue clamp when vincristine was being primed.The set was discarded.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
Date of manufacture 11/11/2015 - 11/12/2015.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.
|
|
Search Alerts/Recalls
|