Catalog Number H938740 |
Device Problem
Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the blue rubber stopper went inside an exactamix 2000ml eva total parenteral nutrition (tpn) bag.This event occurred during an unspecified process step.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
The corrected date is (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
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
|