ASED 30
Received Jul 16, 2024 · Event occurred Jun 24, 2024
Report 3004122598-2024-00041 · MDR key 19750365
Device
Generic name
Ased 30
Manufacturer
Productos Medline S.a. De C.v.Catalog number
DYNDV1934J
Lot number
24BBS779
Product problems
- Crack
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PER THE FACILITY THE SYRINGE WAS CRACKED. NO ADDITIONAL INFORMATION WAS PROVIDED. 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
PER THE FACILITY THE SYRINGE WAS CRACKED.