MEDLINE

Description of Event or Problem

THE SYRINGE PLUNGER BROKE OFF WHILE THE CONTRAST AGENT WAS BEING ADMINISTERED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING THE PROCEDURE, THE SYRINGE PLUNGER BROKE OFF WHILE THE CONTRAST AGENT WAS BEING ADMINISTERED, AND A HIGH-PRESSURE INJECTION LINE (122 CM) WAS USED BETWEEN THE VALVE BLOCK AND THE CATHETER. THE FORCE EXERTED ON THE SYRINGE MAY ALSO HAVE PLAYED A ROLE. IT IS UNCLEAR WHETHER BOTH FACTORS HAD AN INFLUENCE. (USE OF THIS SYRINGE IN THE PRESSURE SYSTEM. AS AN ALTERNATIVE TO THE MEDLINE RECALL PRESSURE SYSTEM.) THEREFORE, IT WAS NOT USED DURING AN OCT PROCEDURE, FOR WHICH WE ORIGINALLY INCLUDED THE SYRINGE IN OUR PRODUCT RANGE. TOOK ANOTHER ONE AFTER THIS OCCURRED. PATIENT IS DOING FINE NOW. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.