UNIVERSAL BLOCK TRAY
Received Mar 4, 2024 · Event occurred Jun 8, 2022
Report 1417592-2024-00136 · MDR key 18826384
Device
Generic name
Universal Block Tray
Manufacturer
Medline Industries, LpModel number
DYNJRA1259ALot number
22DLA974
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT UNSPECIFIED PARTICULATE WAS FOUND WITHIN A SYRINGE COMPONENT. NO PATIENT INVOLVEMENT WAS REPORTED. 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. A SAMPLE WAS RETURNED FOR EVALUATION. A GRAY-WHITE PARTICULATE WAS OBSERVED ON THE TOP OF THE RUBBER SEAL OF THE PLUNGER. THE PARTICULATE WAS NOT FREE FLOATING WITHIN THE SYRINGE BARREL. 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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT UNSPECIFIED PARTICULATE WAS FOUND WITHIN A SYRINGE COMPONENT.