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
Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device history review was completed on the reported lot number v2b263.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The actual complaint sample was returned for evaluation already activated.The root cause was determined to be a cut pouch.It is very unlikely this pouch was cut before leaving the manufacturing site; the product was not reworked, and employees are not to open shippers using sharp instruments.Further, shipper artwork instructs ¿do not use knife to open.¿ therefore, the root cause is likely due to the customer failing to follow packaging directions.We will continue to monitor trends for this product.
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Event Description
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When the nurse went to activate the package it exploded into her hand.She was not hurt, she quickly washed it off she stated it was a slight burning sensation but nothing else.
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Search Alerts/Recalls
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