Catalog Number 515003 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that when using a bd phaseal¿ injector luer lock n35 there was coring when using the drug carfilzomib.Core was isolated to the vile, but medication had to be reconstituted.
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Manufacturer Narrative
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Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be performed as no lot information was provided.Based on the available information we were not able to fully investigate this issue therefore a root cause cannot be determined at this time.This complaint can't be confirmed.
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Event Description
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It was reported that when using a bd phaseal¿ injector luer lock n35 there was coring when using the drug carfilzomib.Core was isolated to the vile, but medication had to be reconstituted.
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Search Alerts/Recalls
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