MEDLINE

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, THE SYRINGE BECAME DISCONNECTED FROM THE MANIFOLD AT THE BEGINNING OF THE PROCEDURE, REQUIRING SETUP OF A NEW HAND INJECTION PACK AND PROLONGING THE PROCEDURE. 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

ACCORDING TO THE FACILITY, THE SYRINGE BECAME DISCONNECTED FROM THE MANIFOLD AT THE BEGINNING OF THE PROCEDURE, REQUIRING SETUP OF A NEW HAND INJECTION PACK AND PROLONGING THE PROCEDURE.