NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received Apr 17, 2023 · Event occurred Jan 1, 1980
Report 1423537-2023-00908 · MDR key 16757589
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V2H168
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
SAMPLES WERE RECEIVED FOR EVALUATION AND THE INVESTIGATION DETERMINED THAT SOME OF THE SAMPLES RECEIVED WERE 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 V2H168, 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.
Description of Event or Problem
CUSTOMER REPORTED THAT TWO INFANT HEEL WARMERS EXPLODED WHILE TRYING TO ACTIVATE. OPERATOR OF DEVICE IS UNKNOWN. EVENT DATE IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED UPON REQUEST.