UNIVERSAL BLOCK TRAY

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON 04/29/2025 THE SYRINGE IS "DEFECTIVE" AND THE "RUBBER STOPPER IS DETACHED". PER THE FACILITY THERE WAS NO PATIENT INVOLVEMENT, AND THEREFORE NO INJURY OR MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 ON (B)(6) 2025 THE SYRINGE IS "DEFECTIVE" AND THE "RUBBER STOPPER IS DETACHED."