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Model Number 11443-012B |
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 03/16/2023 |
Event Type
malfunction
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Event Description
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Customer reported that pack exploded upon activation in nursery, hitting a father.No injury occurred.No further information was provided.
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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.A review of the device history record for the reported lot v3c270 was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Cardinal health will continue to monitor and trend all similar reported product related issues.
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Search Alerts/Recalls
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