OMNIFLUSH
Received Mar 30, 2026 · Event occurred Mar 3, 2026
Report 2027791-2026-00008 · MDR key 24727612
Device
Generic name
Syringe, 10ml Saline In 10ml
Manufacturer
Excelsior MedicalCatalog number
EM-3513576
Lot number
3145987
Product problems
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "SYRINGE BENT. SYRINGE FOUND WITH A DEFORMED PLUNGER." 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
SYRINGE BENT. SYRINGE FOUND WITH A DEFORMED PLUNGER.