NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received Apr 7, 2023 · Event occurred Jan 1, 1980
Report 1423537-2023-00896 · MDR key 16702875
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V2S056E
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER HAS REPORTED THAT WHEN NURSE TRIED TO ACTIVATE A CARDINAL HEALTH INFANT HEEL WARMER THE PACK RUPTURED, LEAKING ON THE HAND, ARM, LEG, SCRUBS, AND SHOES. NO INJURY WAS REPORTED THE STAFF MEMBER IS DOING FINE.
Additional Manufacturer Narrative
THREE SAMPLES WERE RECEIVED FOR EVALUATION, ONE WAS ALREADY ACTIVATED. THE ROOT CAUSE OF THE LEAK WAS DUE TO A TORN POUCH CAUSED BY THE HYPO BUBBLE PIERCING THE POUCH. THE MACHINE WAS SETUP CORRECTLY AND IS DESIGNED WITH A MECHANISM WHICH REDUCES THE LIKELIHOOD FOR THIS ISSUE. ALL PREVENTATIVE MAINTENANCE WAS PERFORMED AS ASSIGNED. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2S056. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE OF LEAK AND WORK TO IDENTIFY IMPROVEMENT ACTIVITIES TO MINIMIZE REOCCURRENCE.