MalfunctionMPO
CARDINAL HEALTH INFANT HEEL WARMER
Received Jul 21, 2021 · Event occurred Jul 17, 2021
Report MW5102702 · MDR key 12210758
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, Llc.Model number
CAT.11460-010TCatalog number
11460-010T
Lot number
V1E144 B
Product problems
- Burst Container or Vessel
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
AS PATIENT CARE ASSISTANT WAS SQUEEZING CARDINAL HEALTH INFANT HEEL WARMER TO ACTIVATE IT, A SIDE SEAM BURST OPEN AND THE CONTENTS SPILLED ON THE INSIDE OF THE CRIB, HAND RAIL OF THE BABY CRIB AND ON THE FLOOR. FDA SAFETY REPORT ID # (B)(4).