MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE SYRINGE WAS UNTHREADING FROM THE MANIFOLD EVEN THOUGH IT WAS FIRMLY ATTACHED. THEY HAD TO OPEN A NEW HAND INJECTION KIT IN THE MIDDLE OF THE PROCEDURE. THE FACILITY STATES THIS PUTS THE PATIENT AT RISK FOR AIR EMBOLUS, HOWEVER NO INJURY OCCURRED AND NO MEDICAL INTERVENTION REQUIRED DUE TO THIS MALFUNCTION. ONLY A 5-10 PROCEDURAL DELAY TO OPEN A NEW KIT WAS REPORTED. NO ADDITIONAL INFORMATION AT THIS TIME. 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

SYRINGE WAS UNTHREADING FROM THE MANIFOLD EVEN THOUGH IT WAS FIRMLY ATTACHED.

Additional Manufacturer Narrative

UPDATED H6, H7, H10.