UNIVERSAL BLOCK TRAY
Received Aug 8, 2025 · Event occurred Jul 21, 2025
Report 1417592-2025-00375 · MDR key 22749667
Device
Generic name
Universal Block Tray
Manufacturer
Medline Industries, LpCatalog number
DYNJRA1223A
Lot number
25DMG482
Product problems
- Material Deformation
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT ON (B)(6) 2025, THE TIP OF A 5ML SYRINGE WAS FOUND TO BE "DEFORMED" PRIOR TO THE BEGINNING OF THE PROCEDURE. THE CUSTOMER STATED THAT THE SYRINGE WAS REPLACED FROM ROOM STOCK SUPPLIES AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THE CUSTOMER REPORTED THAT THERE WAS NO HARM CAUSED TO THE PATIENT. 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
IT WAS REPORTED THAT ON (B)(6) 2025, THE TIP OF A 5ML SYRINGE WAS FOUND TO BE "DEFORMED" PRIOR TO THE BEGINNING OF THE PROCEDURE. THE CUSTOMER STATED THAT THE SYRINGE WAS REPLACED FROM ROOM STOCK SUPPLIES AND THE PROCEDURE WAS ABLE TO BE COMPLETED.