SYRINGE, 10ML SALINE IN 10ML

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, "WE HAVE NOW HAD ONE MORE INCIDENT WHERE WE AT CT WERE ABLE TO VERIFY AIR IN THE BLOODSTREAM AFTER INJECTION WITH OMNIFLUSH." 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. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR (B)(4) ON (B)(6) 2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

ACCORDING TO THE FACILITY, "WE HAVE NOW HAD ONE MORE INCIDENT WHERE WE AT CT WERE ABLE TO VERIFY AIR IN THE BLOODSTREAM AFTER INJECTION WITH OMNIFLUSH."