INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Aug 26, 2022 · Event occurred Jul 21, 2022
Report 1423537-2022-00830 · MDR key 15301591
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
UNKNOWN
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 A HEEL WARMER WAS OBTAINED TO PERFORM A HEEL STICK. UPON SQUEEZING THE SIDES OF THE HEEL WARMER, PER INSTRUCTION, THE LIQUID EXPLODED OUT THE TOP. THE LIQUID LANDED ON THE CHILD'S MOTHER. ACCORDING TO THE WITNESS STATEMENT, "A TINY DROP OF THE LIQUID INSIDE THE WARMER" LANDED ON THE CHILD'S MOTHER LEG. AT THE TIME OF THE INCIDENT, THE CHILD'S MOTHER ASKED FOR A PAPER TOWEL TO WIPE OFF THE LIQUID BUT DID NOT REPORT ANY INJURY. NO DEMOGRAPHIC INFORMATION PROVIDED.
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY REPORT WAS COMPLETED ON THE REPORTED LOT NUMBER, V2C227. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED ON 3/23/22 AND RELEASED TO PREDETERMINED SPECIFICATIONS. MAINTENANCE RECORDS WERE ALSO REVIEWED. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO PHYSICAL SAMPLES WERE RETURNED DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. SAMPLE PHOTOS WERE REVIEWED, BUT WE ARE STILL NOT ABLE TO DETERMINE A ROOT CAUSE BASED ON EVALUATION OF PHOTOS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE.