It was reported that two (2) syringe components from the pack cracked during use.No serious injury or adverse impact to a patient or a user was originally reported.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.Two (2) samples were returned for evaluation and a crack going from the luer lock to the top of the syringe barrel was observed.The root cause was determined to be mishandling of the component at some point during its life cycle.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
|