inforMED
MalfunctionOGJ

MEDLINE

Received Jun 19, 2026 · Event occurred May 21, 2026

Report 1417592-2026-02800 · MDR key 25568342

Device

Generic name

Tray, Universal Block, No Pharm

Catalog number

PAIN9013S

Lot number

26BBG207

Product problems

  • Leak/Splash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PVP PREP SOLUTION LEAKED IN THE PACK.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PVP PREP SOLUTION LEAKED IN THE PACK. 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.