ASED 30
Received Jul 1, 2025 · Event occurred Jun 18, 2025
Report 1417592-2025-00322 · MDR key 22370427
Device
Product problems
- Missing Information
- Missing Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY "WE OPENED THE KIT AND WERE NOT ABLE TO USE THE SYRINGE AS THE NUMBERS ARE ILLEGIBLE". PER THE FACILITY "WE HAD TO OPEN A NEW STERILE SYRINGE TO COMPLETE THE PROCESS". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 (B)(4) 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
ACCORDING TO THE FACILITY "WE OPENED THE KIT AND WERE NOT ABLE TO USE THE SYRINGE AS THE NUMBERS ARE ILLEGIBLE".