Catalog Number JC7790 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/22/2019 |
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 a blood recipient set leaked at the distal end where the tubing connects to the connector.It was further reported that there was a "few mls" of blood that leaked.This was identified during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.Functional test including pressure and clear passage under water testing were performed and the device performed according to product specifications.The reported condition was not verified.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
|