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 05/02/2022 |
Event Type
malfunction
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Event Description
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Customer has reported that the heel warmer busted open before placing it on the patient.No injury, the heel warmer was thrown in the trash without incident.
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Manufacturer Narrative
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Supplemental report is being filed since data for section h10 was missing in the original submission.Device history record review was completed on the reported lot number, v2b110.The lot was found to have been manufactured on february 10, 2022 and released to predetermined specifications.No anomalies were found during review of the records.No samples were returned for evaluation therefore a root cause could not be determined.Cardinal health will continue to monitor complaint trends for this issue.
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