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 - MexicaliCatalog 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.