MEDLINE
Received Dec 11, 2025 · Event occurred Oct 28, 2025
Report 3004122598-2025-00014 · MDR key 23780218
Device
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT ON (B)(6) 2025 THERE WAS "STYROFOAM IN SYRINGE". THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY, MEDICAL INTERVENTION REQUIRED, OR FOLLOW-UP CARE NEEDED AS A RESULT OF THE REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. 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
IT WAS REPORTED THAT ON (B)(6) 2025 THERE WAS "STYROFOAM IN SYRINGE". THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY, MEDICAL INTERVENTION REQUIRED, OR FOLLOW-UP CARE NEEDED AS A RESULT OF THE REPORTED ISSUE.