MEDLINE
Received Jun 4, 2026 · Event occurred May 7, 2026
Report 1417592-2026-02002 · MDR key 25399637
Device
Generic name
Tray, Universal Block, No Pharm
Manufacturer
Productos Medline S.a. De C.v.Catalog number
PAIN9013S
Lot number
26BBG206
Product problems
- Premature Activation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PVP PREP SOLUTION HAS LEAKED AND DAMAGED ALL OF THE COMPONENTS INSIDE THE KIT. CUSTOMER DISCARDED BOTH KITS AND PULLED NEW ONES. DAMAGED KITS FOUND DURING UNBOXING PROCESS. NOT USED ON PATIENT. 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
THE PVP PREP SOLUTION HAS LEAKED AND DAMAGED ALL OF THE COMPONENTS INSIDE THE KIT. CUSTOMER DISCARDED BOTH KITS AND PULLED NEW ONES.