NAMIC

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, DURING A HAND INJECTION PROCEDURE, THE 3-WAY TAP AND SYRINGE WERE INITIALLY CONNECTED. AFTER THE ANGIOGRAM USING APPROXIMATELY 100 ML OF CONTRAST, THE CONNECTION BEGAN TO LOOSEN, AND THE SYRINGE CONNECTION STARTED ROLLING AND EVENTUALLY FELL OFF DURING ANGIOPLASTY FOLLOWED BY ANGIOGRAM. THE SYRINGE WAS REPLACED; HOWEVER, THE SAME ISSUE OCCURRED. THE OPERATOR SUSPECTED THE 3-WAY TAP WAS CONTRIBUTING TO THE PROBLEM AND REPORTED HAVING TO MANUALLY HOLD BOTH THE SYRINGE AND THE TAP IN PLACE WHILE INJECTING CONTRAST TO PREVENT DISCONNECTION. A PROCEDURAL DELAY OF APPROXIMATELY FIVE MINUTES OCCURRED. THE OPERATOR AND ASSISTANT HELD THE TAP AND SYRINGE DURING CONTRAST INJECTION TO PREVENT FURTHER DISCONNECTION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE FACILITY, DURING A HAND INJECTION PROCEDURE, THE 3-WAY TAP AND SYRINGE WERE INITIALLY CONNECTED. AFTER THE ANGIOGRAM USING APPROXIMATELY 100 ML OF CONTRAST, THE CONNECTION BEGAN TO LOOSEN, AND THE SYRINGE CONNECTION STARTED ROLLING AND EVENTUALLY FELL OFF DURING ANGIOPLASTY FOLLOWED BY ANGIOGRAM. THE SYRINGE WAS REPLACED; HOWEVER, THE SAME ISSUE OCCURRED. THE OPERATOR SUSPECTED THE 3-WAY TAP WAS CONTRIBUTING TO THE PROBLEM AND REPORTED HAVING TO MANUALLY HOLD BOTH THE SYRINGE AND THE TAP IN PLACE WHILE INJECTING CONTRAST TO PREVENT DISCONNECTION. A PROCEDURAL DELAY OF APPROXIMATELY FIVE MINUTES OCCURRED. THE OPERATOR AND ASSISTANT HELD THE TAP AND SYRINGE DURING CONTRAST INJECTION TO PREVENT FURTHER DISCONNECTION.

Additional Manufacturer Narrative

UPDATE TO A2, A3A, B5, AND H6: AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE INFORMATION PREVIOUSLY PROVIDED IN THESE SECTIONS WAS INCORRECT. THE DEMOGRAPHIC INFORMATION OF THE PATIENT IS UNKNOWN. ACCORDING TO THE CUSTOMER, THE "SYRINGE COMING LOOSE FROM MANIFOLD AND ALLOWING AIR INTO CLOSED CIRCUIT". NO HEALTH IMPACT OCCURRED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, THE "SYRINGE COMING LOOSE FROM MANIFOLD AND ALLOWING AIR INTO CLOSED CIRCUIT".