UNIVERSAL BLOCK TRAY

Description of Event or Problem

IT WAS REPORTED THAT UNSPECIFIED PARTICULATE WAS FOUND WITHIN A SYRINGE COMPONENT.

Additional Manufacturer Narrative

IT WAS REPORTED THAT UNSPECIFIED PARTICULATE WAS FOUND WITHIN A SYRINGE COMPONENT. NO PATIENT INVOLVEMENT WAS REPORTED. 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. A DARK PARTICULATE WAS OBSERVED TO BE WITHIN THE SYRINGE DURING EVALUATION OF MATERIAL PROVIDED BY THE REPORTING FACILITY. 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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.