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MalfunctionOFF

PAIN MANAGEMENT TRAY

Received Dec 31, 2025 · Event occurred Dec 9, 2025

Report 1417592-2025-00759 · MDR key 23934243

Device

Generic name

Pain Management Tray

Catalog number

DYNDA3217

Lot number

25HBI005

Product problems

  • Fluid/Blood Leak
  • Fluid/Blood Leak

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE SYRINGES ARE "LEAKING". DUE TO THIS THERE IS A "SLIGHT DELAY DUE TO HAVING TO OPEN MULTIPLE SYRINGE".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

LEAKING SYRINGE.