MalfunctionMPO
CARDINAL HEALTH
Received Jun 10, 2022 · Event occurred May 3, 2022
Report 14653075 · MDR key 14653075
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2C242
Product problems
- Material Rupture
Patient
Unknown
- Fluid Discharge
- Fluid Discharge
Narrative
Description of Event or Problem
WHILE ACTIVATING THE HEATING MECHANISM OF THE HEEL WARMER, THE PACKET RUPTURED CAUSING THE GEL INSIDE OF THE PACKET TO SPRAY OUT ONTO THE NURSE.