MEDLINE
Received May 26, 2026 · Event occurred Apr 29, 2026
Report 1417592-2026-01744 · MDR key 25294487
Device
Generic name
Tray, Universal Block, No Pharm
Manufacturer
Productos Medline S.a. De C.v.Catalog number
PAIN9013S
Lot number
26BBG208
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BETADINE HAS LOOSE CAPS AND LEAKING ONTO ALL THE STERILE PRODUCTS.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BETADINE HAS LOOSE CAPS AND LEAKING ONTO ALL THE STERILE PRODUCTS. TECHS IN THE ROOM HAD TO OPEN NEW PACKS. THIS HAS OCCURRED OVER A PERIOD OF A COUPLE OF WEEKS. STILL RECEIVING DAMAGED PKS. NO ADVERSE EFFECTS/PATIENT IS GOOD. 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.