inforMED
MalfunctionFTN

MEDLINE

Received Jul 21, 2026 · Event occurred Jun 22, 2026

Report 1423395-2026-00414 · MDR key 25893780

Device

Generic name

Plastics Pack-lf

Catalog number

DYNJ16539O

Lot number

26BMI083

Product problems

  • Detachment of Device or Device Component

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE RADIOPAQUE TAG COMPONENT DETACHED FROM THE THREADED BEAD ASSEMBLY.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE RADIOPAQUE TAG COMPONENT DETACHED FROM THE THREADED BEAD ASSEMBLY. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.