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Model Number 11443-512B |
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 08/18/2023 |
Event Type
malfunction
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Event Description
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Per medwatch report #(b)(4), after popping hot pack, user noted crystalizing substance coming out from hot pack with no injury to the patient.Intended procedure was to place hot pack on arm to help find veins.
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Manufacturer Narrative
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The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
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Manufacturer Narrative
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As no samples were returned for evaluation, a root cause could not be determined.The device history record review was completed on the reported lot v3b181, and the lot was manufactured and released in compliance with all requirements.Cardinal health has made a business decision to close the site which manufactures product 11443-512b and transition to a third-party manufacturer.
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Search Alerts/Recalls
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