inforMED
MalfunctionFDE

MEDLINE

Received Jun 30, 2026 · Event occurred Jun 3, 2026

Report 1423395-2026-00327 · MDR key 25667966

Device

Generic name

Delnor Cysto Pack

Manufacturer

Medline - Mexicali

Catalog number

DYNJ82272A

Lot number

26DMH037

Product problems

  • Premature Activation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE BETADINE WAS LEAKING. THE PACK WAS NOT USED. QA CONCERN WAS REPORTED VIA MEDPACK APP. 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.

Description of Event or Problem

BETADINE LEAKING.