MEDLINE
Received Jun 17, 2026 · Event occurred May 20, 2026
Report 1417592-2026-02602 · MDR key 25540333
Device
Generic name
Tray, Universal Block, No Pharm, Ea
Manufacturer
Productos Medline S.a. De C.v.Catalog number
PAIN9013SH
Lot number
26BBG207
Product problems
- Premature Activation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ONE OF THE BETADINE BOTTLES BROKE OPEN INSIDE OF ONE OF THE TRAYS AND SATURATED THE PAPER.
Additional Manufacturer Narrative
IT WAS REPORTED THAT ONE OF THE BETADINE BOTTLES BROKE OPEN INSIDE OF ONE OF THE TRAYS AND SATURATED THE PAPER. REP WAS CONTACTED, AND CONNECTED CUSTOMER TO THE RETURNS DEPARTMENT. THIS WAS NEVER USED ON A PATIENT OR AT ALL. SHIPPING BOX WAS DAMAGED. 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.