INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Nov 22, 2022 · Event occurred Oct 25, 2022
Report 1423537-2022-00863 · MDR key 15843465
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2C235D
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SUPPLEMENTAL REPORT IS BEING FILED FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT SUBMITTED ON 11/22/2022 SINCE SAMPLES WERE RETURNED FOR INVESTIGATION. DEVICE HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER, V2C235D. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. SIX ACTIVATED SAMPLES WERE RETURNED FOR INVESTIGATION AND DISPLAYED A TOP SEAL LEAK. THE EXACT ROOT CAUSE FOR BURST WAS NOT DETERMINED. THE MANUFACTURING SITE WILL CONTINUE TO MONITOR COMPLAINT TRENDS.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER: V2C235D. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR INVESTIGATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING SITE WILL CONTINUE TO MONITOR COMPLAINT TRENDS.
Description of Event or Problem
CUSTOMER REPORTED, WE ARE HAVING ISSUES WITH THE HEEL WARMERS BUSTING AND THE CONTENTS GOT INTO THE PATIENT'S CAREGIVER EYE. NO MEDICATION WAS GIVEN, BUT THE CAREGIVER EYES WERE FLUSHED. I WOULD LIKE TO REPORT IT AS A PRODUCT FAILURE. NO DEMOGRAPHICS OR ADDITIONAL INFORMATION PROVIDED.