MalfunctionODC
LUER-SPLIT
Received Jan 30, 2026 · Event occurred Jan 5, 2026
Report 9610595-2026-10448 · MDR key 24225525
Device
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING REPROCESSING THE LUER-SPILT FORCEPS/IRRIGATION PLUG WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.