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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 09/06/2023 |
Event Type
malfunction
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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 could not be performed as a lot was not provided.Cardinal health has made a business decision to close the site which manufactures product 11460-010t and transition to a third-party manufacturer.Cardinal health will continue to monitor complaint trends for this reported issue.
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Event Description
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Customer reported activating large instant hot pack for patient use at charge desk when it burst.The contents landed on carpet floor, sleeve, bicep area, and on two seats.The contents were brushed off arm, shirt, and then nursing supervisor of incident (barb) was notified.Housekeeping notified and present for proper clean up.
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Search Alerts/Recalls
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