NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received Apr 14, 2023 · Event occurred Mar 21, 2023
Report 1423537-2023-00903 · MDR key 16747813
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V2S056
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 REPORTED, THAT THE NICU TEAM HAD INFANT HEEL WARMERS EXPLODE WHILE BEING ACTIVATED. THE GEL LANDED ON THE NURSE¿S MASK AND FACE SHIELD. NO INJURY WAS REPORTED. THEY HAVE PULLED THE FOLLOWING LOT FROM ALL BABY UNITS.
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED FOR EVALUATION. AND THE INVESTIGATION DETERMINED, THAT THE SAMPLE RECEIVED WAS ALREADY ACTIVATED AND DEFECT REPORTED WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A BURST PACK, DUE TO AN INCOMPLETE TOP SEAL. THE MACHINE WAS SETUP CORRECTLY AND IS DESIGNED WITH A MECHANISM, WHICH REDUCES THE LIKELIHOOD FOR THIS ISSUE. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2S056. AND THE LOT WAS MANUFACTURED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE OF BURST AND WORK TO IDENTIFY IMPROVEMENT ACTIVITIES TO MINIMIZE REOCCURRENCE.