MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT "MANIFOLD AND SYRINGE CONNECTION WAS A BIT LOOSE FROM THE BEGINNING, WHEN FILLED WITH CONTRAST THE SYRINGE WAS TOTALLY LOOSE AND SCREWED OUT ITSELF". 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 CFN 1417592 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.

Description of Event or Problem

LOOSE SYRINGE TO MANIFOLD CONNECTION.