ASED 30
Received Apr 12, 2024 · Event occurred Mar 18, 2024
Report 1417592-2024-00492 · MDR key 19098318
Device
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY "THE TECHNICIAN SET UP THEIR STERILE FILED AND WHEN THEY WENT TO USE THE SYRINGE, THEY WERE UNABLE TO, DUE TO ITS CONDITION".
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY "THE TECHNICIAN SET UP THEIR STERILE FILED AND WHEN THEY WENT TO USE THE SYRINGE, THEY WERE UNABLE TO, DUE TO ITS CONDITION". PER THE FACILITY AN ADDITIONAL STERILE SYRINGE WAS REQUIRED. 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 (B)(6) 2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.