DBD-ASED 40
Received Mar 18, 2024 · Event occurred May 13, 2022
Report 3004122598-2024-00018 · MDR key 18927196
Device
Generic name
Dbd-ased 40
Manufacturer
Productos Medline S.a. De C.v.Model number
DYNDV2384CLot number
22CBS279
Product problems
- Break
- Break
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 BROKEN SYRINGE COMPONENT.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PACK CONTAINED A BROKEN SYRINGE COMPONENT. THE TYPE OF BREAK WAS NOT SPECIFIED BY THE REPORTING FACILITY. 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 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.