CONTROL,SYRINGE,12ML,PAD,ROT,L/L,PC

Additional Manufacturer Narrative

IT WAS REPORTED THAT ON (B)(6) 2025, THE CUSTOMER HAD DIFFICULTY ASPIRATING FLUIDS THROUGH THE MANIFOLD INTO THE SYRINGE AND THAT "FLUID ESCAPED PAST THE BLACK RUBBER PLUNGER" INSIDE THE CONTROL SYRINGE DURING A LEFT HEART CATH PROCEDURE. THE CUSTOMER SAID THE DEVICE WAS REPLACED WITH A SYRINGE FROM ROOM STOCK SUPPLIES AND THE PROCEDURE WAS ABLE TO BE COMPLETED. 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

IT WAS REPORTED THAT ON (B)(6) 2025, THE CUSTOMER HAD DIFFICULTY ASPIRATING FLUIDS THROUGH THE MANIFOLD INTO THE SYRINGE AND THAT "FLUID ESCAPED PAST THE BLACK RUBBER PLUNGER" INSIDE THE CONTROL SYRINGE DURING A LEFT HEART CATH PROCEDURE.