Catalog Number ZMC7401 |
Device Problems
Backflow (1064); Disconnection (1171); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/04/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E1: initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a stopcock was loose and disconnected which resulted in a leak and backflow of a patient¿s blood.This issue was further described as, ¿loose and disconnected with the pinless joint¿ and ¿vein blood backflow¿.The event occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
H10: the actual device was not available; however, three (3) retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified on the retained samples.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
|