Catalog Number ZMC7401 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/21/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
E1: initial reporter facility name : (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a stopcock in blister pack was cracked which resulted in a leak.The event occurred when attempting to connect the stopcock to an iv infusion extension line.The stopcock was replaced.There was no patient involvement.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.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
|