MalfunctionMPO
NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received May 1, 2023 · Event occurred Jan 1, 1980
Report 1423537-2023-00922 · MDR key 16849735
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
UNKNOWN
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
30 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE HEAL WARMER BURST WHEN THE PHLEBOTOMIST ATTEMPTED TO USE IT. THERE WAS NO INJURY OR ADVERSE EFFECT REPORTED.
Additional Manufacturer Narrative
AT THE TIME OF THIS INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE VERIFIED AS A LOT NUMBER WAS NOT PROVIDED. A SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR COMPLAINT TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.