NOVAPLUS
Received Jul 17, 2023 · Event occurred Jul 10, 2023
Report 17331936 · MDR key 17331936
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
V11460-010Catalog number
V11460-010
Lot number
V3A159F
Product problems
- Fluid/Blood Leak
- Material Rupture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHLEB TECH ATTEMPTED TO ACTIVATE HEEL WARMER TO USE ON A PATIENT WITH DIFFICULT VENOUS ACCESS IN LATE AFTERNOON. TECH SQUEEZED THE PACK TO ACTIVATE AND THE PACK BURST AND LEAKED ALL OVER THE PATIENT'S BED. TECH STATES THAT THE PATIENT WAS NOT INJURED AND HE CLEANED UP THE CONTENTS OFF THE BED. TECH WAS NOT AFFECTED BY THE LEAKED PRODUCT. NOTE: THERE WAS A RECALL ON THIS PRODUCT JUNE 16, 2023 BUT THE LOT NUMBER RECALLED WAS DIFFERENT (V2S506). THIS LOT NUMBER MAY ALSO BE AFFECTED AND SHOULD BE REPORTED TO CARDINAL HEALTH.