CARDINAL HEALTH 200, LLC INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)
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Model Number 11460-010T |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2022 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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