ASED 15
Received Mar 18, 2024 · Event occurred Sep 25, 2023
Report 3004122598-2024-00030 · MDR key 18927193
Device
Generic name
Ased 15
Manufacturer
Productos Medline S.a. De C.v.Model number
DYNDV2383DLot number
23FBA632
Product problems
- Crack
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PACK CONTAINED A CRACKED SYRINGE COMPONENT.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PACK CONTAINED A CRACKED SYRINGE COMPONENT. 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. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED FOR EVALUATION AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.