Catalog Number H938742 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/22/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from an unspecified location.The leak was discovered prior to patient use.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
H10:the device was received for evaluation.A visual inspection was done which observed a small tear at the lower right side edge of the bag.Magnified inspection identified the tear above the bottom right side shoulder port weld.Functional testing was performed with tap water which revealed a leak from the lower right side edge of the sample.The reported condition was verified.The cause of the tear could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|