MEDLINE
Received Apr 14, 2026 · Event occurred Mar 17, 2026
Report 1423395-2026-00086 · MDR key 24872329
Device
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- Laceration(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "WHEN PROVIDER WAS USING SYRINGE, THE FLANGE BROKE OFF CUTTING THEIR HAND." 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 BROKE DURING USE.
Additional Manufacturer Narrative
UPDATED H6.